PINNACLE RSS602Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00389701007472), received between May 19, 2016 and Feb 11, 2025 — classified as 7 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (16 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 33 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 11, 2025Difficult to Remove; Difficult to Remove

  TERUMO MEDICAL RECEIVED MEDWATCH # (B)(4). THE EVENT DESCRIPTION STATES THAT: AN ELDERLY FEMALE WITH PERSISTENT ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE UNDERWENT AN ELECTROPHYSIOLOGY STUDY WITH DRUG STIMULATION AND ABLATION OF ATRIAL FIBRILLATION OF THE PULMONARY VEIN. UPON REMOVAL OF THE LEFT FEMORAL ARTERIAL SHEATH, THE DISTAL PORTION OF THE SHEATH WAS RETAINED AND COULD NOT BE ACCESSED PERCUTANEOUSLY. THE PROVIDER ELECTED TO LEAVE THE RETAINED PORTION IN PLACE. THERE WAS EVIDENCE OF GOOD HEMOSTASIS NOTED ON ULTRASOUND AS WELL AS FOLLOWING MANUAL COMPRESSION. THE SL2 SHEATH WAS REMOVED AND LEFT THE SHORT 8-FRENCH SHEATH IN PLACE ON THE RIGHT SIDE. ADDITIONALLY, WE PLACED A RIGHT FEMORAL ARTERIAL 5-FRENCH SHEATH FOR BLOOD PRESSURE MONITORING. AT THIS POINT, WE CONCLUDED THE PROCEDURE. THE PATIENT WAS EXTUBATED AND TRANSPORTED TO THE HOLDING AREA FOR FURTHER OBSERVATION AND BED REST. A SURGICAL CONSULTATION WAS OBTAINED, AND THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR EMERGENT EXPLORATION OF THE LEFT COMMON FEMORAL ARTERY AND THE LEFT COMMON FEMORAL VEIN, WITH REPAIR OF THE LEFT COMMON FEMORAL ARTERY IN TWO LOCATIONS ANTERIORLY AND POSTERIORLY, AND EXPLORATION OF TH

  Patient problems: Embolism/Embolus; Foreign Body In Patient

  MAUDE report 21360210 ↗
• InjurySep 6, 2024Material Deformation; Material Deformation

  TERUMO MEDICAL OBTAINED AN FDA MEDWATCH REPORT # MW5157015. THE EVENT DESCRIPTION STATES THAT SHEATH & CATHETER BECAME KINKED DURING HEART CATHETERIZATION REQUIRING VASCULAR SURGEON INTERVENTION TO ELIMINATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20155592 ↗
• InjuryMay 10, 2024Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE SHEATH BROKE INSIDE OF A PATIENT. IT WAS RETRIEVED AND SAVED. ADDITIONAL INFORMATION WAS RECEIVED ON 17APR2024: THE PROCEDURE BEING PERFORMED WAS A LEFT HEART DIAGNOSTIC ANGIO VIA RIGHT FEMORAL ACCESS. WHEN ATTEMPTING TO REMOVE THE SHEATH THEY PULLED UNTIL IT SEPARATED. ALL PIECES OF SHEATH WERE REMOVED IN THE CATH LAB. THE PATIENT WAS SENT TO SURGERY FOR ENDORACTOMY PATCH AND HEMATOMA EVACUATION. SIZE OF HEMATOMA WAS NOT RECEIVED. NO HISTORY OF FEMORAL CLOSURE AT THIS HOSPITAL. GROWING SHOT TAKEN, HOWEVER, NOT AVAILABLE AT THIS TIME. REPORTED BLOOD LOSS WAS LESS THAN 250ML. THE PATIENT WAS STABLE.

  Patient problems: Hematoma

  MAUDE report 19288710 ↗
• InjuryAug 12, 2023Fracture; Fracture

  THE USER FACILITY REPORTED THAT THEY HAD A RIGHT GROIN ACCESS WITH 6 FR SHEATH (RSS602). ACCESS WAS OBTAINED WITHOUT DIFFICULTY, SINGLE STICK. PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) OF THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) PERFORMED AND TRANSFERRED TO RECOVERY. WHEN TIME FOR REMOVAL OF SHEATH POST PROCEDURE, THERE WERE UNABLE TO REMOVE SHEATH WITHOUT DILATOR FOR MANUAL PRESSURE. TRANSFERRED PATIENT TO PROCEDURE ROOM. MULTIPLE GROIN SHOTS PERFORMED NO ISSUES OR COMPLICATIONS NOTED. ADVANCED A DILATOR, SHEATH REMOVED WITH SOME RESISTANCE, MANUAL PRESSURE APPLIED, AND TEAR/NICK NOTED ON SHEATH. SURGEON CONSULTED FOR OPINION AND NO INTERVENTION WAS REQUIRED. THE VESSEL WAS CALCIFIED. GROIN SITE AND PATIENT BOTH STABLE. PATIENT WAS IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS SUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17537840 ↗
• MalfunctionJun 10, 2023Leak/Splash; Leak/Splash

  ADDITIONAL INFORMATION WAS RECEIVED ON 19 MAY 2023: THE TYPE OF PROCEDURE PERFORMED WAS A LOWER LEG ANGIOGRAPHY. THE HUB WAS NOT DAMAGED. THE PROCEDURE WAS NOT COMPLETED, PROCEDURE CONCLUDED WHEN BLOOD WAS NOTICED AT FEMORAL ACCESS SITE. IK DEVICE WAS REMOVED, AND PROCEDURE CONCLUDED. ESTIMATED BLOOD LOSS WAS LESS 250 CCS. ADDITIONAL INFORMATION WAS RECEIVED ON 20 JUN 2023: ACCORDING TO THE PHYSICIAN THERE WAS NO SUTURE USED AND AND NO DIFFICULTY WITH INSERTING THE SHEATH.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17102104 ↗
• InjuryNov 26, 2022Break; Break

  A MAUDE DATABASE SEARCH CONDUCTED ON 30 OCT 2022 FOUND A MAUDE REPORT NUMBER 15484674. THE EVENT DESCRIPTION STATES: WHILE USING THE CATHETER IN CATH LAB, THE PATIENT MOVED SUDDENLY AND THE DISTAL 3/5 OF THE CATHETER SHEARED OFF AND LODGED IN THE PATIENT'S ILIAC ARTERY. THE INTERVENTIONALIST HAD GREAT DIFFICULTY RETRIEVING THE CATHETER PIECE AND THE PATIENT REACHED MAXIMUM OR NEAR MAXIMUM RADIATION EXPOSURE. THE PHYSICIAN FELT IT WAS SAFE TO LEAVE AND RETURN TO ATTEMPT RETRIEVAL ANOTHER DAY. THE RETRIEVAL WAS SUCCESSFUL. THE PATIENT CAME INTO THE HOSPITAL IN EXTREMIS, BUT THIS CATHETER EVENT DID NOT EXACERBATE HER CLINICAL CONDITION.

  Patient problems: Foreign Body In Patient

  MAUDE report 15867026 ↗
• MalfunctionAug 16, 2021Difficult to Advance; Difficult to Advance

  THE USER FACILITY REPORTED THAT THE IK DEVICE CATHETER COULD NOT BE PASSED EASILY THROUGH THE SHEATH ONCE FEMORAL ACCESS WAS OBTAINED. A 6FR GUIDE WAS USED WITH THE IK DEVICE. THE SHEATH WAS REMOVED AND ANOTHER CORDIS 6FR SHEATH WAS USED. THE CASE WAS COMPLETED NORMALLY. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE WAS COMPLETED NORMALLY. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 27JULY2021: THE PROCEDURE WAS A PERCUTANEOUS CORONARY INTERVENTION (PCI).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12324999 ↗
• MalfunctionFeb 16, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT THE IK SHEATH WAS MISSING THE THREE WAY STOP COCK UPON OPENING THE SHEATH. THE CASE WAS A LEFT HEART CATHETERIZATION (LHC). THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PATIENT WAS KNOWN TO BE IN STABLE CONDITION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER SHEATH. ADDITIONAL INFORMATION WAS RECEIVED ON 08DEC2020. THE SHEATH IS USUALLY FLUSHED WITH SALINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11334201 ↗
• MalfunctionOct 5, 2020Material Deformation; Material Deformation

  ADDITIONAL INFORMATION WAS RECEIVED ON 21OCTOBER2020: THE SIDE TUBE OR THE SHEATH WAS NOT EXPOSED TO ANY SOURCES OF HEAT AT ANY TIME DURING THE PROCEDURE. THE PINHOLE WAS NOT NOTED WHEN THE SHEATH WAS PREPPED. THE SHEATHS WERE STORED IN THE BOX THEY COME IN. THIS WAS THE ONLY SHEATH WHICH HAD THIS DAMAGE. ADDITIONAL INFORMATION WAS RECEIVED ON 10NOVEMBER2020: IT WAS REPORTED THAT THE DOCTOR USES A POWER INJECTOR 2/3RDS OF THE TIME DURING A PROCEDURE. THERE WAS A GOOD CHANCE IT WAS USED. THE DILATOR WAS NOT IN WHEN CONTRAST MEDIA WAS PUT IN. THERE WERE NO ISSUES NOTED ON THE SHEATH WHILE IT WAS FLUSHED. THE SHEATH WAS PLACED IN THE PATIENT. THE SIDE PORT DID BECOME KINKED PRIOR TO THE GROIN ANGIOGRAM. WHEN THE GROIN ANGIOGRAM WAS TAKEN, THE HOLE WAS NOTICED. NOT SURE HOW OR WHEN THE SIDE PORT BECAME KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10627757 ↗
• InjuryAug 25, 2020Break; Break

  THE USER FACILITY REPORTED THAT THE TIP OF THE SHEATH BROKE OFF WHEN REMOVING THE SHEATH AT THE END OF THE CASE. THE COMMON FEMORAL ARTERY WAS FAIRLY CALCIFIED. THE DOCTOR HAD TO SNARE THE BROKEN PIECE OUT AND EVERYTHING WAS OK. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS SUCCESSFUL. THE BLOOD LOSS WAS LESS THAN 250 CC'S. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 19AUG2020: TERUMO MEDICAL RECEIVED AN FDA MEDWATCH REPORT # MW5095582. THE EVENT DESCRIPTION STATES: "DURING INTRA-OP ANGIOGRAM, INDUCER TIP CAME OFF WHEN SURGEON WAS PLACING THE GUIDEWIRE. SURGEON WAS ABLE TO RETRIEVE THE TIP FROM THE PATIENT."

  Patient problems: Blood Loss

  MAUDE report 10449228 ↗
• MalfunctionJan 30, 2020Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT WHEN THE IK VALVE WAS TURNED OFF TO THE PATIENT, AND HAD BEEN FLUSHED, BLOOD WAS STILL GETTING INTO THE SHEATH. THE PHYSICIAN WAS CONCERNED THAT CLOTS BUILD UP IN THE SHEATH AND THEN WHEN HE ADVANCES THE CATHETER, HE IS PUSHING THE CLOT UP THE AORTA WITH THE CATHETER. ADDITIONAL INFORMATION WAS RECEIVED ON 08JAN2020. THE CASE WAS REPORTED TO BE EITHER A HEART CATHETERIZATION OR A PERIPHERAL LEG CASE. THE CASE WAS SUCCESSFUL AND WAS COMPLETED WITH THE SAME SHEATH. THE EVENT DID NOT LEAD TO BLOOD LOSS, THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9649239 ↗
• MalfunctionJan 30, 2020Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT WHEN THE IK VALVE WAS TURNED OFF TO THE PATIENT, AND HAD BEEN FLUSHED, BLOOD WAS STILL GETTING INTO THE SHEATH. THE PHYSICIAN WAS CONCERNED THAT CLOTS BUILD UP IN THE SHEATH AND THEN WHEN HE ADVANCES THE CATHETER, HE IS PUSHING THE CLOT UP THE AORTA WITH THE CATHETER. ADDITIONAL INFORMATION WAS RECEIVED ON 08JAN2020. THE CASE WAS REPORTED TO BE EITHER A HEART CATHETERIZATION OR A PERIPHERAL LEG CASE. THE CASE WAS SUCCESSFUL AND WAS COMPLETED WITH THE SAME SHEATH. THE EVENT DID NOT LEAD TO BLOOD LOSS, THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9649238 ↗
• MalfunctionJan 30, 2020Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT WHEN THE IK VALVE WAS TURNED OFF TO THE PATIENT, AND HAD BEEN FLUSHED, BLOOD WAS STILL GETTING INTO THE SHEATH. THE PHYSICIAN WAS CONCERNED THAT CLOTS BUILD UP IN THE SHEATH AND THEN WHEN HE ADVANCES THE CATHETER, HE IS PUSHING THE CLOT UP THE AORTA WITH THE CATHETER. ADDITIONAL INFORMATION WAS RECEIVED ON 08JAN2020. THE CASE WAS REPORTED TO BE EITHER A HEART CATHETERIZATION OR A PERIPHERAL LEG CASE. THE CASE WAS SUCCESSFUL AND WAS COMPLETED WITH THE SAME SHEATH. THE EVENT DID NOT LEAD TO BLOOD LOSS, THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9649237 ↗
• MalfunctionJan 29, 2020Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT WHEN THE IK VALVE WAS TURNED OFF TO THE PATIENT, AND HAD BEEN FLUSHED, BLOOD WAS STILL GETTING INTO THE SHEATH. THE PHYSICIAN WAS CONCERNED THAT CLOTS BUILD UP IN THE SHEATH AND THEN WHEN HE ADVANCES THE CATHETER, HE IS PUSHING THE CLOT UP THE AORTA WITH THE CATHETER. ADDITIONAL INFORMATION WAS RECEIVED ON 08JAN2020. THE CASE WAS REPORTED TO BE EITHER A HEART CATHETERIZATION OR A PERIPHERAL LEG CASE. THE CASE WAS SUCCESSFUL AND WAS COMPLETED WITH THE SAME SHEATH. THE EVENT DID NOT LEAD TO BLOOD LOSS, THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9642623 ↗
• MalfunctionJan 29, 2020Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT WHEN THE IK DEVICE VALVE IS TURNED OFF TO THE PATIENT AND IT HAS BEEN FLUSHED, BLOOD IS STILL GETTING INTO THE SHEATH. THE PHYSICIAN IS CONCERNED CLOT BUILDS UP IN THE SHEATH AND THEN WHEN HE ADVANCES THE CATHETER, HE IS PUSHING CLOT UP THE AORTA WITH THE CATHETER. ADDITIONAL INFORMATION WAS RECEIVED 08JANUARY2019: THE CASE PERFORMED WAS A HEART CATHETERIZATION OR A PERIPHERAL LEG CASE. THE PROCEDURE OUTCOME WAS SUCCESSFUL, THIS ISSUE DID NOT LEAD TO BLOOD LOSS. THE PATIENT WAS STABLE AND THE CASE WAS COMPLETED WITH THE SAME SHEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9641619 ↗
• MalfunctionJan 29, 2020Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT WHEN THE IK DEVICE VALVE IS TURNED OFF TO THE PATIENT AND IT HAS BEEN FLUSHED, BLOOD IS STILL GETTING INTO THE SHEATH. THE PHYSICIAN IS CONCERNED CLOT BUILDS UP IN THE SHEATH AND THEN WHEN HE ADVANCES THE CATHETER, HE IS PUSHING CLOT UP THE AORTA WITH THE CATHETER. ADDITIONAL INFORMATION WAS RECEIVED 08JANUARY2019: THE CASE PERFORMED WAS A HEART CATHETERIZATION OR A PERIPHERAL LEG CASE. THE PROCEDURE OUTCOME WAS SUCCESSFUL, THIS ISSUE DID NOT LEAD TO BLOOD LOSS. THE PATIENT WAS STABLE AND THE CASE WAS COMPLETED WITH THE SAME SHEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9641617 ↗
• MalfunctionJan 29, 2020Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT WHEN THE IK DEVICE VALVE IS TURNED OFF TO THE PATIENT AND IT HAS BEEN FLUSHED, BLOOD IS STILL GETTING INTO THE SHEATH. THE PHYSICIAN IS CONCERNED CLOT BUILDS UP IN THE SHEATH AND THEN WHEN HE ADVANCES THE CATHETER, HE IS PUSHING CLOT UP THE AORTA WITH THE CATHETER. ADDITIONAL INFORMATION WAS RECEIVED 08JANUARY2019: THE CASE PERFORMED WAS A HEART CATHETERIZATION OR A PERIPHERAL LEG CASE. THE PROCEDURE OUTCOME WAS SUCCESSFUL, THIS ISSUE DID NOT LEAD TO BLOOD LOSS. THE PATIENT WAS STABLE AND THE CASE WAS COMPLETED WITH THE SAME SHEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9641616 ↗
• MalfunctionJan 29, 2020Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT WHEN THE IK DEVICE VALVE IS TURNED OFF TO THE PATIENT AND IT HAS BEEN FLUSHED, BLOOD IS STILL GETTING INTO THE SHEATH. THE PHYSICIAN IS CONCERNED CLOT BUILDS UP IN THE SHEATH AND THEN WHEN HE ADVANCES THE CATHETER, HE IS PUSHING CLOT UP THE AORTA WITH THE CATHETER. ADDITIONAL INFORMATION WAS RECEIVED 08JANUARY2019: THE CASE PERFORMED WAS A HEART CATHETERIZATION OR A PERIPHERAL LEG CASE. THE PROCEDURE OUTCOME WAS SUCCESSFUL, THIS ISSUE DID NOT LEAD TO BLOOD LOSS. THE PATIENT WAS STABLE AND THE CASE WAS COMPLETED WITH THE SAME SHEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9641614 ↗
• MalfunctionJan 28, 2020Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT WHEN THE IK VALVE WAS TURNED OFF TO THE PATIENT, AND HAD BEEN FLUSHED, BLOOD WAS STILL GETTING INTO THE SHEATH. THE PHYSICIAN WAS CONCERNED THAT CLOTS BUILD UP IN THE SHEATH AND THEN WHEN HE ADVANCES THE CATHETER, HE IS PUSHING THE CLOT UP THE AORTA WITH THE CATHETER. ADDITIONAL INFORMATION WAS RECEIVED ON 08JAN2020. THE CASE WAS REPORTED TO BE EITHER A HEART CATHETERIZATION OR A PERIPHERAL LEG CASE. THE CASE WAS SUCCESSFUL AND WAS COMPLETED WITH THE SAME SHEATH. THE EVENT DID NOT LEAD TO BLOOD LOSS, THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9637253 ↗
• MalfunctionJan 28, 2020Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT WHEN THE IK VALVE WAS TURNED OFF TO THE PATIENT, AND HAD BEEN FLUSHED, BLOOD WAS STILL GETTING INTO THE SHEATH. THE PHYSICIAN WAS CONCERNED THAT CLOTS BUILD UP IN THE SHEATH AND THEN WHEN HE ADVANCES THE CATHETER, HE IS PUSHING THE CLOT UP THE AORTA WITH THE CATHETER. ADDITIONAL INFORMATION WAS RECEIVED ON 08JAN2020. THE CASE WAS REPORTED TO BE EITHER A HEART CATHETERIZATION OR A PERIPHERAL LEG CASE. THE CASE WAS SUCCESSFUL AND WAS COMPLETED WITH THE SAME SHEATH. THE EVENT DID NOT LEAD TO BLOOD LOSS, THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9637248 ↗
• MalfunctionJan 7, 2020Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THE INVOLVED IK DEVICE WAS USED AND WHILE FLUSHING THE SHEATH PRIOR TO INSERTING INTO PATIENT, IT WAS NOTICED TO BE KINKED IN THE MIDDLE OF THE SHAFT. ANOTHER IDENTICAL SHEATH WAS OPENED AND USED TO COMPLETE THE PROCEDURE. THE PATIENT'S CONDITION WAS STABLE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PROCEDURE WAS A LEFT HEART CATHETERIZATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9559821 ↗
• MalfunctionDec 12, 2019Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT IK DEVICE VALVE WAS LEAKING.

  Patient problems: No Information

  MAUDE report 9458393 ↗
• MalfunctionDec 12, 2019Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE IK DEVICE VALVE WAS LEAKING.

  Patient problems: No Information

  MAUDE report 9458370 ↗
• MalfunctionOct 29, 2019Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THERE WAS A CRIMPED AREA NOTED ON THE SHAFT OF THE IK SHEATH. THIS WAS DISCOVERED PRIOR TO USING OR ATTEMPTING TO USE THE DEVICE. A NEW SHEATH WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY. THE PROCEDURE OUTCOME WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED ON 10OCT2019. THE PROCEDURE WAS A HEART CATHETERIZATION / PERCUTANEOUS CORONARY INTERVENTION (PCI). THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9251765 ↗
• MalfunctionJun 10, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED ON JUNE 28, 2019. THE TYPE OF PROCEDURE WAS A CARDIAC CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8683434 ↗