Bridge Occlusion Balloon 590-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 00813132024840), received between Aug 16, 2018 and Mar 30, 2026 — classified as 4 deaths, 18 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (11 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 57 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Difficult to Advance

  A LEAD EXTRACTION PROCEDURE COMMENCED TO TREAT A PATIENT. DURING PROPHYLACTIC STAGING OF A SPECTRANETICS BRIDGE OCCLUSION BALLOON DEVICE TO BE USED IN THE EVENT OF AN EMERGENCY, RESISTANCE WAS ENCOUNTERED AND WOULD NOT ADVANCE WHEN TRYING TO INSERT THE BALLOON OVER THE NON-PHILIPS GUIDEWIRE. A NEW NON-PHILIPS GUIDEWIRE WAS USED, AND THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT HARM. THIS REPORT CAPTURES THE BRIDGE BALLOON THAT WOULD NOT ADVANCE OVER THE GUIDEWIRE; POTENTIAL FOR HARM IF IT WAS TO RECUR IN THE EVENT OF AN EMERGENCY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24734545 ↗
• MalfunctionMay 29, 2025Difficult to Advance; Difficult to Advance

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) LEAD DUE TO MRI AND NON-FUNCTION. A RIGHT ATRIAL (RA) AND LEFT VENTRICULAR (LV) WERE PRESENT WITHIN THE PATIENT, BUT NOT TARGETED FOR EXTRACTION. A SPECTRANETICS LLD EZ LEAD LOCKING DEVICE (LLD EZ) WAS INSERTED INTO THE LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 16F GLIDELIGHT, PROGRESS WAS MADE TO THE PROXIMAL COIL OF THE LEAD. THEN, SWITCHING TO A SPECTRANETICS 13F TIGHTRAIL ROTATING DILATOR SHEATH, ADVANCEMENT WAS MADE OVER THE PROXIMAL COIL, WHEN THE PATIENT¿S BLOOD PRESSURE DROPPED. TRACTION ON THE LLD EZ WAS RELEASED, AND THE PATIENT STABILIZED. NEXT, THE TIGHTRAIL ADVANCED TO THE DISTAL COIL, BUT COULD NOT PROGRESS FURTHER DUE TO THE STIFFNESS OF THE OUTER SHEATH. WHEN REMOVING THE TIGHTRAIL FROM THE PATIENT TO ELIMINATE THE OUTER SHEATH, THE BLOOD PRESSURE DROPPED, AND A PERICARDIAL EFFUSION WAS DETECTED VIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). RESCUE EFFORTS BEGAN, INCLUDING CPR AND THE USE OF A SPECTRANETICS BRIDGE OCCLUDING BALLOON. THE BALLOON WAS ADVANCED UP THE GUIDEWIRE, BUT WOULD NOT ADVANCE PAST THE IVC (MDR # .). USE OF THE BRIDGE WAS ABANDONED, STERNOTOMY WAS PERFORMED, AND TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22108025 ↗
• MalfunctionApr 30, 2025Material Rupture; Material Rupture

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) LEADS DUE TO BACTEREMIA. SPECTRANETICS LLD EZ LEAD LOCKING DEVICES (LLD EZS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. PRIOR TO THE PROCEDURE, A SPECTRANETICS BRIDGE OCCLUDING BALLOON WAS PROPHYLACTICALLY INFLATED TO ENSURE SUPERIOR VENA CAVA (SVC) OCCLUSION IN THE EVENT THAT AN EMERGENCY OCCURRED. THE BRIDGE WAS PLACED ON THE GUIDE WIRE AND ADVANCED TO THE SVC. THE BALLOON WAS INFLATED USING A 60 CC SYRINGE FILLED WITH CONTRAST MIXTURE, DEFLATED, AND STAGED IN THE INFERIOR VENA CAVA (IVC). BEGINNING WITH A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH, AND SWITCHING BETWEEN THE RA AND RV LEAD, THERE WAS VERY LITTLE ADVANCEMENT; THEREFORE, THE DECISION WAS MADE TO SNARE THE LEADS FROM BELOW. THE BRIDGE WAS REMOVED; HOWEVER, UPON REMOVAL, A TEAR WAS NOTED. A NEW SHEATH WAS INSERTED, AND A NEW BRIDGE WAS STAGED, AND THE LEADS WERE REMOVED SUCCESSFULLY VIA SNARE, WITH NO REPORTED PATIENT HARM. THIS REPORT CAPTURES THE BRIDGE OCCLUSION BALLOON (RESCUE BALLOON) THAT RUPTURED, POTENTIAL FOR HARM WITH RECURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21936273 ↗
• MalfunctionFeb 21, 2025Material Rupture; Material Rupture

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) AND A RIGHT ATRIAL (RA) LEAD DUE TO CIED SYSTEM/POCKET INFECTION. PRIOR TO THE PROCEDURE, A SPECTRANETICS BRIDGE OCCLUDING BALLOON WAS PROPHYLACTICALLY INFLATED TO ENSURE SUPERIOR VENA CAVA (SVC) OCCLUSION IN THE EVENT THAT AN EMERGENCY OCCURRED. THE BRIDGE WAS PLACED ON THE GUIDE WIRE AND ADVANCED TO THE SVC. THE BALLOON WAS INFLATED USING A 60 CC SYRINGE FILLED WITH CONTRAST MIXTURE. DURING DEFLATION, BLOOD WAS NOTICED IN THE SYRINGE, SO IT WAS REMOVED FROM THE PATIENT. UPON REMOVAL, A HOLE WAS NOTED NEAR THE BASE OF THE BALLOON; PHYSICIAN SUSPECTED IT MAY HAVE BEEN TORN BY THE CALCIUM IN THE VESSEL. A NEW BRIDGE DEVICE WAS STAGED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTED PATIENT HARM. THIS REPORT CAPTURES THE BRIDGE OCCLUSION BALLOON (RESCUE BALLOON) THAT RUPTURED DURING STAGING, POTENTIAL FOR HARM WITH RECURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21437683 ↗
• DeathMay 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE WAS SCHEDULED TO REMOVE A LEAD LOCATED IN THE BUNDLE OF HIS AND REPLACE IT WITH A LEFT VENTRICULAR (LV) LEAD. A RIGHT ATRIAL (RA) AND A RIGHT VENTRICULAR (RV) LEAD WERE BOTH PRESENT IN THE PATIENT AS WELL, BUT WERE NOT TARGETED FOR EXTRACTION. THE SYSTEM HAD BEEN IMPLANTED FROM THE RIGHT SIDE, BECAUSE THE PATIENT HAD OCCLUSION OF THE LEFT SUBCLAVIAN AND INNOMINATE VEINS. AN INITIAL ATTEMPT TO REMOVE THE HIS LEAD OCCURRED IN AN EP LAB BUT WAS UNSUCCESSFUL, SO THE CASE WAS RESCHEDULED TO BE PERFORMED IN THE HYBRID OR. PRE-PROCEDURALLY, A VENOGRAM REVEALED STENOSIS AND OCCLUSION OF THE SUPERIOR VENA CAVA (SVC), AND A TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) DETECTED A MINOR BASELINE EFFUSION ON THE RIGHT SIDE OF THE HEART, NEAR THE RA. DUE TO THIS BEING A HIGH RISK CASE, A SPECTRANETICS BRIDGE OCCLUSION BALLOON WAS BEING PROPHYLACTICALLY "STAGED" PRIOR TO THE PROCEDURE WITHIN THE SVC, IN THE EVENT AN INJURY WAS TO OCCUR DURING THE EXTRACTION PROCEDURE. DURING STAGING, THE GUIDE WIRE (ON WHICH THE BRIDGE BALLOON ADVANCES) WAS INSERTED FEMORALLY TO THE CLAVICLE AREA BEFORE MEETING RESISTANCE. THE PATIENT'S RIGHT INTERNAL JUGULAR WAS OCCLUDED, SO THE GUIDE WIRE

  Patient problems: Great Vessel Perforation; Pericardial Effusion

  MAUDE report 19282311 ↗
• InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) LEAD DUE TO NON-FUNCTION. NO IMAGING WAS PERFORMED BEFORE THE EXTRACTION. PRIOR TO THE PROCEDURE, A SPECTRANETICS BRIDGE OCCLUSION BALLOON WAS PROPHYLACTICALLY ''STAGED'' WITHIN THE PATIENT'S INFERIOR VENA CAVA (IVC). IN THE EVENT OF AN EMERGENCY, THE BRIDGE BALLOON COULD BE POSITIONED AND INFLATED QUICKLY WITHIN THE SUPERIOR VENA CAVA (SVC) TO PROVIDE OCCLUSION AS A RESCUE MEASURE. A SPECTRANETICS LEAD LOCKING DEVICE (LLD) WAS INSERTED INTO THE RV LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS GLIDELIGHT LASER SHEATH AND A SPECTRANETICS VISISHEATH DILATOR SHEATH, THE RV LEAD WAS EXTRACTED SUCCESSFULLY. THE BRIDGE BALLOON REMAINED IN THE PATIENT FOR APPROXIMATELY ONE HOUR WHILE THE CASE WAS COMPLETED; EMERGENT USE OF BRIDGE WAS NOT REQUIRED. THE BRIDGE WAS THEN REMOVED FROM THE PATIENT, WITH NO THROMBUS OBSERVED. HOWEVER, POST-PROCEDURE, THE PHYSICIAN NOTICED A LARGE CLOT IN THE RA ON ECHO, AND WAS CONCERNED IT MAY HAVE HAD TO DO WITH THE BRIDGE IN-DWELL TIME WITHIN THE PATIENT. THE CLOT DISSOLVED ON ITS OWN, WITH NO FURTHER INTERVENTION OR TREATMENT REQUIRED. NO PATIENT INJURY WAS REPORTED, AND THE

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18143601 ↗
• MalfunctionOct 23, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  THIS EVENT IS NO LONGER REPORTABLE FOR THE BRIDGE BALLOON, REPORTED IN THE INITIAL MDR THAT IT BECAME STUCK ON THE GUIDE WIRE. AT DEVICE EVALUATION, THE LABORATORY GUIDE WIRE ADVANCED SUCCESSFULLY THROUGH THE BRIDGE BALLOON. THERE IS NO POTENTIAL FOR HARM IF THE EVENT WAS TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17991981 ↗
• MalfunctionJul 10, 2023Material Deformation; Material Deformation

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT ATRIAL (RA) AND A RIGHT VENTRICULAR (RV) LEAD DUE TO BACTEREMIA. DURING PREPARATION TO STAGE A SPECTRANETICS BRIDGE OCCLUSION BALLOON TO BE USED IN THE EVENT OF AN EMERGENCY, IT WAS OBSERVED THAT THE BALLOON WAS ENLARGED AT THE TIP, WHEN THE PROTECTIVE SLEEVE WAS REMOVED. IT WAS CONSIDERED TO BE TOO ENLARGED TO INSERT THROUGH THE FEMORAL SHEATH, SO ANOTHER BRIDGE BALLOON WAS OPENED AND USED TO PROPHYLACTICALLY STAGE WITHIN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT HARM. THIS REPORT CAPTURES THE BRIDGE BALLOON WHICH WAS ENLARGED AT THE TIP, POTENTIAL FOR HARM IF IT WAS TO RECUR IN THE EVENT OF AN EMERGENCY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17292876 ↗
• MalfunctionMar 31, 2023Failure to Advance; Failure to Advance

  THIS EVENT IS NO LONGER REPORTABLE FOR THE BRIDGE BALLOON, REPORTED IN THE INITIAL MDR THAT IT WOULD NOT ADVANCE OVER THE GUIDE WIRES. AT DEVICE EVALUATION, BOTH THE RETURNED GUIDE WIRE AND A LABORATORY GUIDE WIRE ADVANCED SUCCESSFULLY THROUGH THE BRIDGE BALLOON. THERE IS NO POTENTIAL FOR HARM IF THE EVENT WAS TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16658264 ↗
• DeathMar 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEAD FOR AN UPGRADE TO A BIVENTRICULAR ICD SYSTEM (PATIENT HAD SIGNIFICANT MEDICAL HISTORY/COMORBIDITIES). PRIOR TO THE PROCEDURE, A SPECTRANETICS BRIDGE OCCLUSION BALLOON WAS PROPHYLACTICALLY ''STAGED'' WITHIN THE PATIENT'S INFERIOR VENA CAVA (IVC). IN THE EVENT OF AN EMERGENCY, THE BRIDGE BALLOON COULD BE POSITIONED AND INFLATED QUICKLY WITHIN THE SUPERIOR VENA CAVA (SVC) TO PROVIDE OCCLUSION OF THE SVC AS A RESCUE MEASURE. SPECTRANETICS DEVICES (GLIDELIGHT LASER SHEATH, LEAD LOCKING DEVICES (LLDS)) WERE USED TO SUCCESSFULLY EXTRACT BOTH LEADS. RE-IMPLANTATION OF A NEW RV AND THE ADDITION OF AN LV LEAD WAS COMPLETED. THE BRIDGE BALLOON REMAINED IN THE PATIENT FOR 1 HOUR, 42 MINUTES WHILE THE CASE WAS COMPLETED; USE OF BRIDGE WAS NOT REQUIRED. THE BRIDGE WAS THEN REMOVED FROM THE PATIENT, WITH NO THROMBUS OBSERVED. THE PATIENT SURVIVED THE PROCEDURE, AND LAID FLAT FOR THE MANDATED 4 HOURS PRIOR TO BEING DISCHARGED. AS THE PATIENT WAS GETTING DRESSED,  HE SUDDENLY COLLAPSED, AND A CARDIAC CODE WAS CALLED. DURING THE CODE, TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) WAS USED TO DETECT FOR ANY I

  Patient problems: Pulmonary Embolism

  MAUDE report 16499763 ↗
• MalfunctionJan 6, 2023Failure to Advance; Failure to Advance

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE TWO RIGHT VENTRICULAR (RV) LEADS AND ONE RIGHT ATRIAL (RA) LEAD DUE TO NON FUNCTION. DURING PROPHYLACTIC STAGING OF A SPECTRANETICS BRIDGE OCCLUSION BALLOON DEVICE TO BE USED IN THE EVENT OF AN EMERGENCY, IT WAS DISCOVERED THE DEVICE WAS DIFFICULT TO ADVANCE AND WAS STUCK ON THE DISTAL FLOPPY END OF THE GUIDE WIRE CONTAINED WITHIN THE SPECTRANETICS BRIDGE PREP KIT. A NEW GUIDE WIRE WAS UTILIZED, AND A NEW BRIDGE BALLOON SUCCESSFULLY ADVANCED OVER THE WIRE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO REPORTED PATIENT HARM. THIS REPORT CAPTURES THE BRIDGE BALLOON THAT BECAME STUCK AND WOULD NOT ADVANCE OVER THE GUIDE WIRE; POTENTIAL FOR HARM IF IT WAS TO RECUR IN THE EVENT OF AN EMERGENCY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16117665 ↗
• MalfunctionJan 6, 2023Failure to Advance; Failure to Advance

  A LEAD EXTRACTION PROCEDURE COMMENCED (EXTRACTION INDICATION AND LEAD INFORMATION UNK). DURING PROPHYLACTIC STAGING OF A SPECTRANETICS BRIDGE OCCLUSION BALLOON DEVICE TO BE USED IN THE EVENT OF AN EMERGENCY, IT WAS DISCOVERED THE BALLOON BECAME STUCK ON A MERIT MEDICAL .035 GUIDE WIRE. A NEW BRIDGE BALLOON ADVANCED OVER THE GUIDE WIRE WITH SUCCESS PRIOR TO THE CASE. NO PATIENT INJURY REPORTED. THIS REPORT CAPTURES THE BRIDGE BALLOON THAT BECAME STUCK AND WOULD NOT ADVANCE OVER THE GUIDE WIRE; POTENTIAL FOR HARM IF IT WAS TO RECUR IN THE EVENT OF AN EMERGENCY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16117479 ↗
• MalfunctionAug 31, 2022Failure to Advance; Failure to Advance

  A LEAD EXTRACTION PROCEDURE COMMENCED (EXTRACTION INDICATION AND LEAD INFORMATION UNK). DURING PROPHYLACTIC STAGING OF A SPECTRANETICS BRIDGE OCCLUDING BALLOON DEVICE TO BE USED IN THE EVENT OF AN EMERGENCY, IT WAS DISCOVERED THE BALLOON WOULD NOT ADVANCE OVER THE GUIDE WIRE. A NEW BRIDGE BALLOON ADVANCED OVER THE GUIDE WIRE WITH SUCCESS PRIOR TO THE CASE. NO PATIENT INJURY REPORTED. THIS REPORT CAPTURES THE BRIDGE THAT WAS UNABLE TO ADVANCE OVER THE GUIDE WIRE; POTENTIAL FOR HARM IF IT WAS TO RECUR IN THE EVENT OF AN EMERGENCY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15331841 ↗
• InjuryMay 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE THE FOLLOWING DUE TO INFECTION: RIGHT VENTRICULAR (RV) LEAD (FROM RIGHT CHEST), MODEL 4074, IMPLANTED IN (B)(6) 2021; RV LEAD (2) (FROM LEFT CHEST), MODEL 5076, IMPLANTED IN (B)(6) 2011, CAPPED AND GENERATOR REMOVED DUE TO INFECTION (B)(6) 2021; AND RIGHT ATRIAL (RA) LEAD (FROM LEFT CHEST), MODEL 5076, IMPLANTED IN (B)(6) 2011. PRIOR TO THE PROCEDURE AND FROM A FEMORAL ACCESS, A GUIDE WIRE WAS INSERTED, ADVANCED AND STAGED WITHIN THE INFERIOR VENA CAVA (IVC) IN THE EVENT AN EMERGENCY WOULD NECESSITATE USE OF A SPECTRANETICS BRIDGE OCCLUDING BALLOON CATHETER, WHICH WAS IMMEDIATELY AVAILABLE IN THE BOX. THE BRIDGE BALLOON PROVIDES OCCLUSION AND HEMOSTASIS IF A SUPERIOR VENA CAVA (SVC) PERFORATION WAS TO OCCUR. A SPECTRANETICS LEAD LOCKING DEVICE (LLD) WAS INSERTED INTO RV LEAD (1) ALONG WITH THE USE OF SUTURE FOR TRACTION. COOK MEDICAL LIBERATOR LOCKING STYLETS WERE INSERTED INTO RV LEAD (2) AND RA LEAD, ALONG WITH COOK MEDICAL ONE-TIE COMPRESSION COILS TO PROVIDE TRACTION. THE PHYSICIAN ATTEMPTED REMOVAL OF RV LEAD (1) FROM THE RIGHT CHEST USING A SPECTRANETICS 12F GLIDELIGHT LASER SHEATH. WHILE THE GLIDELIGHT WAS BEING USED IN THE SUB

  Patient problems: Cardiac Perforation

  MAUDE report 14349555 ↗
• MalfunctionFeb 8, 2022Material Puncture/Hole; Material Puncture/Hole

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT ATRIAL (RA) AND A RIGHT VENTRICULAR (RV) LEAD DUE TO BACTEREMIA. PRIOR TO THE PROCEDURE, A SPECTRANETICS BRIDGE OCCLUSION BALLOON WAS PROPHYLACTICALLY INFLATED TO ENSURE SUPERIOR VENA CAVA (SVC) OCCLUSION IN THE EVENT THAT AN EMERGENCY OCCURRED DURING THE PROCEDURE AND REQUIRED USE OF THE BRIDGE BALLOON. THE BRIDGE BALLOON WAS PLACED ON THE GUIDE WIRE AND WAS POSITIONED IN THE SUPERIOR VENA CAVA (SVC). IT WAS THEN PROPHYLACTICALLY INFLATED WITH CONTRAST MIXTURE WITHIN THE PATIENT. UPON DEFLATION OF THE BALLOON, BLOOD WAS OBSERVED IN THE 60 CC SYRINGE. THE BRIDGE BALLOON WAS THEN REMOVED FROM THE PATIENT'S BODY. UPON OBSERVATION OF THE BALLOON OUTSIDE THE BODY, IT WAS DETERMINED THAT THE BALLOON HAD TORN IN SOME WAY. ANOTHER BRIDGE BALLOON WAS USED, AND THE CASE WAS COMPLETED WITH NO REPORTED PATIENT HARM. THERE WAS A TEMPORARY WIRE PRESENT WITHIN THE VASCULATURE AT THE TIME OF BRIDGE BALLOON INFLATION. THIS REPORT CAPTURES THE BRIDGE BALLOON WHICH WAS OBSERVED TO BE TORN, WITH THE POTENTIAL FOR INJURY WITH RECURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13486658 ↗
• MalfunctionFeb 8, 2022Material Puncture/Hole; Material Puncture/Hole

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT ATRIAL (RA) AND A RIGHT VENTRICULAR (RV) LEAD DUE TO RV MALFUNCTION, AND RA NEEDED TO BE REMOVED TO BE MRI COMPATIBLE. SPECTRANETICS LEAD LOCKING DEVICES (LLDS) WERE INSERTED IN BOTH LEADS TO PROVIDE TRACTION. A COOK MEDICAL ONE-TIE COMPRESSION COIL WAS USED ON THE RV LEAD TO PROVIDE ADDITIONAL TRACTION. IT WAS NOTED THAT THE PATIENT WAS OCCLUDED ON THE LEFT SIDE. A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH AND A SPECTRANETICS VISISHEATH DILATOR SHEATH WERE USED TO ATTEMPT REMOVAL OF THE RV LEAD. PROGRESS WAS MADE IN THE VASCULATURE, BUT STALLED IN THE INNOMINATE AREA. THE PHYSICIAN ALTERNATED USE OF THE GLIDELIGHT AND VISISHEATH DEVICES, ULTIMATELY GETTING THROUGH THE BINDING IN THE INNOMINATE/SUPERIOR VENA CAVA (SVC) REGION. ONCE THROUGH THAT AREA, THE RV LEAD CAME FREE WITH TRACTION AND USE OF THE VISISHEATH. NO HEMODYNAMIC CHANGES WERE NOTED AT THE TIME, AND NO COMPLICATIONS WERE SEEN VIA TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE). THE PHYSICIAN NOTICED THAT THE 14F GLIDELIGHT WAS SLIGHTLY BENT AT THE TIP OF THE DEVICE AFTER THE GLIDELIGHT DEVICE WAS TOSSED TO THE SIDE WHEN THE TEMPORARY PACING WIRE LOST CAPTURE (SO NO ISSUE W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13486304 ↗
• MalfunctionDec 30, 2021Failure to Advance; Failure to Advance

  A LEAD EXTRACTION PROCEDURE WAS SCHEDULED TO REMOVE A RIGHT ATRIAL (RA) AND A RIGHT VENTRICULAR (RV) LEAD DUE TO BACTEREMIA (CIED SYSTEM/POCKET INFECTION). PRIOR TO BEGINNING THE CASE, A SPECTRANETICS BRIDGE OCCLUDING BALLOON WAS BEING PREPPED TO BE USED IN THE EVENT AN EMERGENCY OCCURRED DURING THE PROCEDURE. HOWEVER, WHEN THE PHYSICIAN ATTEMPTED TO PLACE THE BRIDGE BALLOON ONTO THE 0.35 GUIDE WIRE, THE BRIDGE WOULD NOT TRACK/ADVANCE OVER THE WIRE. A NEW BRIDGE BALLOON WAS OPENED AND IT WORKED PERFECTLY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTED PATIENT HARM. THIS REPORT CAPTURES THE FIRST BRIDGE BALLOON THAT WOULD NOT TRACK/ADVANCE OVER THE GUIDE WIRE AND THE POTENTIAL FOR HARM IF IT WAS TO RECUR IN THE EVENT OF AN EMERGENCY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13119745 ↗
• MalfunctionJul 23, 2021Failure to Advance; Failure to Advance

  A LEAD EXTRACTION PROCEDURE WAS SCHEDULED TO REMOVE ONE RIGHT VENTRICULAR (RV) LEAD DUE TO NON FUNCTION. PRIOR TO BEGINNING, A SPECTRANETICS BRIDGE OCCLUDING BALLOON WAS BEING PREPPED TO BE USED IN THE EVENT AN EMERGENCY OCCURRED DURING THE PROCEDURE. HOWEVER, WHEN THE TEAM LOADED THE BRIDGE BALLOON ON THE WIRE THAT WAS CONTAINED WITHIN THE BRIDGE PREP KIT, THE WIRE WOULDN'T PASS OUT OF THE BACK END/HUB OF THE BRIDGE BALLOON. THE TEAM THEN TRIED WITH ANOTHER WIRE (AMPLATZ SUPER STIFF) AND TRIED THREADING IT FROM BOTH DIRECTIONS, AND IT WOULD NOT THREAD. THERE REPORTEDLY WAS AN OBSTRUCTION IN THE HUB OF THE BRIDGE BALLOON. A NEW BRIDGE BALLOON WAS OPENED, THREADED SUCCESSFULLY OVER THE SAME WIRE AS THE FIRST, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTED PATIENT HARM. THIS REPORT IS BEING SUBMITTED TO CAPTURE THE FIRST BRIDGE BALLOON THAT WAS UNABLE TO LOAD ONTO THE GUIDE WIRE AND THE POTENTIAL FOR HARM IF IT WERE TO RECUR IN THE EVENT OF AN EMERGENCY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12215976 ↗
• MalfunctionJul 21, 2021Unintended Deflation; Unintended Deflation

  ON 22 JUNE 2021, A PHILIPS REPRESENTATIVE BECAME AWARE (WHO WAS NOT PRESENT AT THE PROCEDURE) THAT A LEAD EXTRACTION PROCEDURE COMMENCED ON (B)(6) 2021 TO REMOVE A RIGHT VENTRICULAR (RV) DUAL COIL LEAD DUE TO NOISE (NON FUNCTION). A SPECTRANETICS LEAD LOCKING DEVICE (LLD) WAS INSERTED INTO THE RV LEAD TO PROVIDE TRACTION TO AID IN THE LEAD'S EXTRACTION; IT WAS REPORTED THAT THE LLD DID NOT REACH THE LEAD'S DISTAL TIP, BUT WAS USED IN THE PROCEDURE. A RIGHT ATRIAL (RA) LEAD WAS PRESENT IN THE PATIENT AS WELL, BUT WAS NOT TARGETED FOR EXTRACTION. THE PHYSICIAN CHOSE A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH TO EXTRACT THE LEAD. DURING THE ATTEMPTED EXTRACTION, A 1-2CM EFFUSION WAS SEEN. RESCUE EFFORTS BEGAN, INCLUDING PERICARDIOCENTESIS, THE NEEDLE ENTERING THE SUBXISPHISTERNAL REGION, AND 2-3 PASSES WITH THE NEEDLE WERE PERFORMED, DIRECTED TOWARDS THE PATIENT'S LEFT SHOULDER. HOWEVER, NO BLOOD WAS DRAWN BACK, SO PERICARDIOCENTESIS WAS ABANDONED. IT WAS REPORTED THAT A SPECTRANETICS BRIDGE OCCLUDING BALLOON CATHETER WAS THEN INSERTED AND INFLATED (OVER 5 MINUTES LATER) TO PROVIDE HEMOSTASIS IN THE SUPERIOR VENA CAVA (SVC) REGION. IT WAS REPORTED THAT THE BRIDGE BALLOON WAS INITIALL

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12207591 ↗
• MalfunctionJul 15, 2021Deflation Problem; Deflation Problem

  A PHILIPS REPRESENTATIVE BECAME AWARE ON 21 JUNE 2021 OF A LEAD EXTRACTION PROCEDURE THAT WAS PERFORMED ON (B)(6) 2021. THE PROCEDURE WAS TO REMOVE A RIGHT ATRIAL (RA) LEAD DUE TO NON FUNCTION. IN ADDITION, ON 08 JULY 2021, THE MANUFACTURER RECEIVED A FACILITY MEDWATCH, REPORT # (B)(4), IN WHICH THE FACILITY AND EVENT DATE MATCHED WITH THE EVENT CAPTURED WITHIN THE MANUFACTURER'S DATABASE, AND CONTAINED SIMILAR DETAILS OF THE EVENT. ACCORDING TO INFORMATION CONTAINED WITHIN THESE TWO REPORTS, A SPECTRANETICS BRIDGE OCCLUDING BALLOON WAS BEING PREPARED IN THE EVENT IT WOULD BE NEEDED FOR USE WITHIN THE SUPERIOR VENA CAVA (SVC) IN THE EVENT OF AN EMERGENCY. ALTHOUGH NO DETAIL COULD BE OBTAINED REGARDING WHEN THE BRIDGE BALLOON WAS INFLATED WITH CONTRAST MEDIUM, THE REPORT STATED THAT AFTER INFLATION, DEFLATION OF THE BALLOON WAS ATTEMPTED, AND INSTEAD OF CONTRAST MEDIUM BEING DRAWN OUT OF THE BALLOON, AIR WAS BEING DRAWN INTO THE SYRINGE INSTEAD. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED WITH NO REPORT OF INJURY THAT WOULD HAVE NECESSITATED USE OF THE BRIDGE BALLOON. IN ADDITION, THE PROCEDURE WAS COMPLETED, THE RA LEAD WAS SUCCESSFULLY EXTRACTED, AND THERE WAS NO REPORTED PAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12177727 ↗
• MalfunctionJun 30, 2021Partial Blockage; Partial Blockage

  A PHILIPS REPRESENTATIVE BECAME AWARE ON 09 JUNE 2021 THAT DURING PREPARATION FOR A LEAD EXTRACTION PROCEDURE WHICH COMMENCED ON (B)(6) 2021 AND WHILE ATTEMPTING TO ADVANCE A SPECTRANETICS BRIDGE OCCLUDING BALLOON OVER THE GUIDE WIRE (TO BE USED IN THE EVENT OF AN EMERGENCY), IT WAS FOUND THAT THE BRIDGE BALLOON WOULD ONLY ADVANCE APPROXIMATELY 1/3 OF THE WAY INTO THE PATIENT''S VESSEL, AND WAS REPORTEDLY BLOCKED WITHIN THE BALLOON. THIS DEVICE WAS REMOVED AND ANOTHER BRIDGE BALLOON WAS SUCCESSFULLY ADVANCED, USING THE SAME GUIDE WIRE AS WITH THE FIRST BALLOON. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO REPORTED PATIENT HARM. THIS REPORT IS BEING SUBMITTED DUE TO THE POTENTIAL OF THIS REPORTED FAILURE CONTRIBUTING TO DEATH OR SERIOUS INJURY IF THE FAILURE WAS TO RECUR DURING AN EMERGENCY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12096019 ↗
• MalfunctionJun 23, 2021Material Puncture/Hole; Material Puncture/Hole

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE TWO LEADS: A RIGHT ATRIAL (RA) LEAD AND A RIGHT VENTRICULAR (RV) LEAD DUE TO CIED SYSTEM/POCKET INFECTION. PRIOR TO THE PROCEDURE, A SPECTRANETICS BRIDGE OCCLUDING BALLOON WAS PROPHYLACTICALLY INFLATED TO ENSURE SUPERIOR VENA CAVA (SVC) OCCLUSION IN THE EVENT THAT AN EMERGENCY OCCURRED DURING THE PROCEDURE AND REQUIRED USE OF THE BRIDGE BALLOON. THE BRIDGE BALLOON WAS PLACED ON THE GUIDE WIRE AND WAS REPORTEDLY POSITIONED IN THE SUPERIOR VENA CAVA (SVC)/RIGHT ATRIAL (RA) JUNCTION. IT WAS THEN PROPHYLACTICALLY INFLATED WITH CONTRAST MIXTURE WITHIN THE PATIENT AND WHEN INFLATED, THE BRIDGE BALLOON REPORTEDLY SLIPPED DOWN INTO THE RIGHT ATRIUM. SUBSEQUENTLY, WHILE DEFLATING THE BRIDGE BALLOON IN ORDER TO ''STAGE'' THE DEVICE WITHIN THE PATIENT FOR ITS USE IF NECESSARY, IT WAS NOTICED THAT BLOOD WAS APPEARING IN THE 60CC SYRINGE USED FOR DEFLATING THE BALLOON. IT WAS DECIDED AT THAT TIME TO REMOVE THE BRIDGE BALLOON FROM THE PATIENT'S BODY. WHEN THE BRIDGE BALLOON WAS OUT OF THE PATIENT, IT WAS RE-INFLATED AGAIN, AND THERE WAS A HOLE NOTED IN THE MIDDLE OF THE BALLOON. ANOTHER DEVICE WAS USED, AND THE CASE WAS COMPLETED SUCCESSFULLY WITH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12050111 ↗
• MalfunctionDec 9, 2020Difficult to Advance; Difficult to Advance

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) AND A RIGHT ATRIAL (RA) LEAD DUE TO NON FUNCTION. PRIOR TO THE PROCEDURE, THE PHYSICIAN WAS ATTEMPTING TO PROPHYLACTICALLY INSERT AND STAGE A BRIDGE OCCLUDING BALLOON TO BE USED IN THE EVENT OF AN EMERGENCY DURING THE PROCEDURE. ACCORDING TO REPORTS FROM THE PHILIPS REPRESENTATIVE WHO WAS PRESENT IN THE PROCEDURE, THE GUIDEWIRE FOR THE BRIDGE BALLOON WAS ONLY ABLE TO ADVANCE A FEW INCHES DUE TO A REPORTED BLOCKAGE WITHIN THE VESSEL. THE GUIDEWIRE WAS THEN REMOVED AND THE PHYSICIAN ATTEMPTED TO INSERT THE BRIDGE BALLOON WITHOUT THE GUIDEWIRE BECAUSE THE BRIDGE BALLOON WAS REPORTEDLY MORE RIGID AND PROVIDED MORE PUSH-ABILITY. AFTER ADVANCING THE BRIDGE BALLOON AS FAR AS POSSIBLE, THE PHYSICIAN THEN INSERTED THE GUIDEWIRE THROUGH THE PROXIMAL END OF THE BALLOON. HOWEVER, DURING INSERTION OF THE GUIDEWIRE INTO THE BRIDGE BALLOON, THE GUIDEWIRE BECAME STUCK INSIDE THE DEVICE'S LUMEN. AT THIS TIME BOTH THE GUIDEWIRE AND THE BRIDGE BALLOON WERE REMOVED FROM THE PATIENT AND A NEW GUIDEWIRE AND BRIDGE BALLOON WERE SUCCESSFULLY USED. THE PROCEDURE WAS REPORTEDLY COMPLETED WITH NO PATIENT HARM. THIS REPORT IS BEING SUBMI

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10976468 ↗
• MalfunctionNov 4, 2020Deflation Problem; Deflation Problem

  DURING A CARDIAC LEAD MANAGEMENT PROCEDURE THE SPECTRANETICS BRIDGE OCCLUSION BALLOON WAS INFLATED PROPHYLACTICALLY IN THE SUPERIOR VENA CAVA (SVC). HOWEVER, WHEN THE PHYSICIAN ATTEMPTED TO DEFLATE THE BALLOON, HE WAS ONLY ABLE TO GET THE SYRINGE 45-50 CC FULL (60 CC SYRINGE WAS USED). AT THAT POINT, THE TEAM NOTICED THAT NO MORE FLUID WOULD COME IN TO THE SYRINGE AND IT LOOKED LIKE AIR WAS COMING INTO THE SYRINGE FROM THE BACK OF THE BALLOON HUB (WIRE INSERTION HUB AREA). FLUOROSCOPY SHOWED THERE WAS STILL A LITTLE FLUID IN THE BALLOON. THE PHYSICIAN DISCONNECTED/RECONNECTED THE SYRINGE AND WAS FINALLY ABLE TO GET THE REST OF THE FLUID OUT. DURING THIS TIME, THE TEAM ALSO NOTICED BLOOD IN THE NECK TUBING OF THE BALLOON, OUTSIDE THE PATIENT'S BODY. BECAUSE OF THIS, THE BRIDGE BALLOON WAS REMOVED FROM THE PATIENT'S BODY AND ANOTHER DEVICE WAS USED. TEST INFLATION ON THE BRIDGE BALLOON AFTER IT WAS REMOVED AND OUTSIDE THE BODY SHOWED THE BALLOON HAD A HOLE IN IT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT HARM. FURTHER FOLLOW UP FROM THE PHILIPS REPRESENTATIVE PRESENT AT THE PROCEDURE REPORTED THAT THERE WERE TWO LEADS THROUGH THE SVC WHEN THE TEAM TEST INFLATED THE BALLOON

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10785863 ↗
• MalfunctionAug 5, 2020Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  A LEAD EXTRACTION PROCEDURE WAS SCHEDULED TO REMOVE ONE RIGHT VENTRICULAR (RV) LEAD DUE TO NON FUNCTION. PRIOR TO BEGINNING, A SPECTRANETICS BRIDGE OCCLUDING BALLOON WAS BEING PREPPED TO BE USED IN THE EVENT AN EMERGENCY OCCURRED DURING THE PROCEDURE. HOWEVER, WHILE ATTEMPTING TO PLACE THE BRIDGE BALLOON ON THE GUIDE WIRE, IT WOULD NOT THREAD ONTO THE WIRE. THE WIRE REPORTEDLY STOPPED APPROXIMATELY 2-3 INCHES FROM THE DEVICE''S TIP. THE BRIDGE BALLOON WAS THEN TURNED AROUND TO SEE IF THE WIRE WOULD THREAD THROUGH THE OPPOSITE WAY BUT STOPPED IN APPROXIMATELY THE SAME AREA. A NEW BRIDGE BALLOON WAS OBTAINED, AND SUCCESSFULLY PLACED ON THE WIRE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT HARM. THIS REPORT IS BEING SUBMITTED DUE TO THIS FAILURE CONTRIBUTING TO A SERIOUS INJURY IF IT WERE TO RECUR DURING AN ADVERSE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10370911 ↗