NC TREK 1012455-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 08717648152146), received between Feb 10, 2017 and Mar 18, 2026 — classified as 2 deaths, 17 injuries, 38 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (36 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Jan 29, 2020Terminated

   Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

   Z-1137-2020 · Root cause: Process change control · FDA record ↗

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 18, 2026Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RIGHT CORONARY ARTERY LESION. A 5 X12 MM NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS PREPARED BEFORE PATIENT USE; HOWEVER, IT WAS DIFFICULT TO REMOVE THE PROTECTIVE SHEATH. THE BDC WAS ADVANCED TO THE TARGET LESION FOR PRE-DILATION WITHOUT ISSUE. HOWEVER, THE BDC WAS UNABLE TO BE FULLY DEFLATED AND WAS UNABLE TO BE RETRACTED BACK INTO THE GUIDING CATHETER. THE SHEATH AND THE ENTIRE DELIVERY SYSTEM WERE REMOVED FROM THE PATIENT AS A WHOLE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24631765 ↗
• MalfunctionNov 8, 2024Material Separation; Failure to Advance; Material Separation; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED LEFT CIRCUMFLEX ARTERY THAT IS 90% STENOSED. DURING ADVANCEMENT OF THE 5.0X12MM NC TREK BALLOON DILATATION CATHETER RESISTANCE WAS MET WITH ANATOMY AND THE SHAFT SEPARATED IN THE GUIDING CATHETER INTO TWO PIECES. THE ENTIRE SYSTEM WAS REMOVED TOGETHER WITH THE SEPARATED PORTION. A NEW NC TREK BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20641565 ↗
• MalfunctionOct 3, 2024Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method; Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method

  SUBSEQUENT TO THE INITIAL REPORT BEING FILED IT WAS REPORTED THAT THERE WAS RESISTANCE NOTED DURING REMOVAL OF THE STYLET OR PROTECTIVE SHEATH AND NEGATIVE PRESSURE WAS HELD FOR 5 SECONDS TO DEFLATE THE BALLOON. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20363600 ↗
• MalfunctionJul 23, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE 5.0X12 MM NC TREK BALLOON DILATATION CATHETER SEPARATED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19807872 ↗
• DeathJul 17, 2024Entrapment of Device; Material Separation; Failure to Deflate; Entrapment of Device; Material Separation; Failure to Deflate

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH MYOCARDIAL INFARCTION (MI). AFTER IMAGING, AN IMPELLA DEVICE WAS INSERTED AND 8 STENTS WERE IMPLANTED IN THE LEFT MAIN ARTERY. THE 5X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS USED FOR POST DILATATION OF ONE OF THE NON-ABBOTT STENTS AND THE BALLOON INFLATED WITHOUT ISSUE; HOWEVER, THE BALLOON FAILED TO DEFLATE. AFTER 15 MINUTES, THE BALLOON WAS PARTIALLY DEFLATED TO WITHDRAWAL THE BDC FROM THE LEFT MAIN ARTERY. DURING REMOVAL THE BALLOON SEPARATED FROM THE DELIVERY SYSTEM IN THE AORTA WHERE AN AORTIC DISSECTION WAS SUSPECTED. THE BALLOON THEN MIGRATED TO THE GROIN WHERE THE BALLOON BECAME STUCK AGAIN; THEREFORE, AN ATTEMPT WAS MADE TO PERFORATE THE BALLOON WITH A WIRE WHICH WAS ULTIMATELY SUCCESSFUL. THE PATIENT WAS STABLE AND TRANSFERRED TO INTENSIVE CARE; HOWEVER, THE PATIENT WENT INTO SHOCK AND SUBSEQUENTLY DIED IN INTENSIVE CARE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Embolism/Embolus; Shock; Vascular Dissection

  MAUDE report 19767559 ↗
• MalfunctionMar 8, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE THE 5.0X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WOULD NOT FULLY DEFLATE. THERE WAS NO ADVERSE PATIENT EFFECTS REPORTED AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18866916 ↗
• MalfunctionDec 13, 2023Difficult to Remove; Material Rupture; Improper or Incorrect Procedure or Method; Difficult to Remove; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% RE-STENOSED STENT IN THE MID RIGHT CORONARY ARTERY (RCA) WITH MILD CALCIFICATION AND MILD TORTUOSITY. THE 5.0X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS USED FOR PRE-DILATATION, HOWEVER, THE BALLOON RUPTURED AT 12 ATMOSPHERES AT THE FIRST INFLATION. THE BDC WAS ATTEMPTED TO REMOVED; HOWEVER, RESISTANCE WAS MET WITH THE GUIDE WIRE; THEREFORE, THE BDC WAS REMOVED WITH THE GUIDE WIRE AS A SINGLE UNIT. IT WAS FURTHER REPORTED THAT THE NC TREK BDC HAD NOT BEEN PREPPED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE. AN NON-ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18318799 ↗
• MalfunctionNov 16, 2023Deflation Problem; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Deflation Problem; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method

  SUBSQUENTLY, AFTER THE INITIAL REPORT WAS FILED, IT WAS NOTED THAT THE NC TREK BALLOON DID NOT SUFFICIENTLY DEFLATE EVEN ON FULL NEGATIVE, AND CYCLED UP TO 2-3 ATMOSPHERES (ATMS) A COUPLE OF TIMES IN THE AORTA. THE BALLOON HAD BEEN USED TWICE (ONCE IN THE LEFT MAIN AND THE OTHER AT THE OSTIUM) UP TO 18 ATMS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18156294 ↗
• InjuryNov 8, 2023Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Failure to Deflate; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Failure to Deflate

  RETURN DEVICE ANALYSIS FOUND THE BALLOON WAS NOT SEPARATED AS REPORTED. ADDITIONALLY A .014" ABBOTT BMW UNIVERSAL II GUIDE WIRE WAS FROZEN IN THE GUIDE WIRE LUMEN OF THE NC TREK BALLOON CATHETER. ADDITIONALLY, FOLLOW UP WITH THE ACCOUNT REPORT THAT INCORRECT CONTRAST RATIO HAD BEEN USED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18096775 ↗
• MalfunctionAug 9, 2023Difficult to Remove; Material Split, Cut or Torn; Failure to Deflate; Difficult to Remove; Material Split, Cut or Torn; Failure to Deflate

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE CIRCUMFLEX ARTERY. THE 5.0X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS PREPARED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE AND THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE SHEATH. THE BALLOON WAS INFLATED TWICE WITH A PRESSURE OF UP TO 16 ATMOSPHERES (ATMS), HOWEVER, COULD NOT BE DEFLATED AT ALL AND WAS WITHDRAWN INFLATED. THE BALLOON GOT STUCK IN THE SHEATH AND THE BALLOON TORE. THE SHEATH, GUIDE CATHETER AND BALLOON WERE ALL REMOVED AS A SINGLE UNIT. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17487904 ↗
• InjuryJul 18, 2023Deflation Problem; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Deflation Problem; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TREAT A TIGHT LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH NO CALCIFICATION OR TORTUOSITY. A 4.5X23 MM XIENCE SKYPOINT STENT WAS IMPLANTED AND THE PROXIMAL SEGMENT WAS DILATED WITH A 5.0X12 MM NC TREK BALLOON CATHETER. THE NC TREK WAS INFLATED 5 TIMES TO 14 ATMOSPHERES AND NEGATIVE WAS HELD FOR AT LEAST 5 SECONDS FOR DEFLATION. WHEN THE BALLOON WAS BEING REMOVED, IT GOT STUCK WITH THE GUIDING CATHETER AND SEPARATED IN THE OSTIAL PART OF THE CATHETER AFTER SOME RESISTANCE. DIFFERENT GUIDE WIRES WERE ATTEMPTED TO BE ADVANCED TO REMOVE THE SEPARATED PORTION, BUT NONE MADE IT THROUGH, THEN IT WAS DECIDED TO REMOVE THE ENTIRE SYSTEM TOGETHER, KEEPING THE SEPARATED BALLOON INSIDE THE CATHETER. THE BALLOON WAS NOTED TO BE STUCK IN THE RADIAL INTRODUCER AND WHEN THE INTRODUCER WAS REMOVED IT WAS FOUND THAT THE BALLOON WAS STILL PARTIALLY INFLATED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. SUBSEQUENT TO FILING THE INITIAL REPORT, THE FOLLOWING INFORMATION WAS PROVIDED: A PHOTO WAS RECEIVED WHICH SHOWED THE BALLOON WAS WITHDRAWN INFLATED AND THE SHAFT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17346441 ↗
• MalfunctionMar 20, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. THE 5.0X8MM NC TREK BALLOON DILATATION CATHETER (BDC)) WAS NOTED TO BE STUCK IN THE IN THE UNSPECIFIED CATHETER AFTER DEFLATION OF THE DEVICE. RESISTANCE WAS NOTED DURING REMOVAL OF THE BDC WITH THE UNSPECIFIED GUIDE CATHETER AND GUIDE WIRE. THE BDC WAS REMOVED AS A ONE UNIT ALONG WITH THE UNSPECIFIED CATHETER AND GUIDE WIRE. A NEW 5.0X12MM NC TREK BDC WAS USED; HOWEVER, SAME ISSUE OCCURRED AND DEVICES WERE REMOVED AS ONE UNIT. A NEW 4.0X18MM NC TREK WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS REPORTED AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16573491 ↗
• InjuryFeb 6, 2023Deflation Problem; Entrapment of Device; Failure to Deflate; Deflation Problem; Entrapment of Device; Failure to Deflate

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE OSTIAL RIGHT CORONARY ARTERY (RCA). AFTER POST DILATATION WITH THE 5.0X12MM NC TREK BALLOON DILATATION CATHETER (BDC) AT 18 ATMOSPHERES, IT WAS NOTED THAT THE BALLOON WOULD NOT DEFLATE AFTER SEVERAL TIMES OF HOLDING NEGATIVE FOR A FEW MINUTES. IT WAS ATTEMPTED TO REMOVE THE BDC AND WAS PULLED TO THE AORTA, BUT THE BALLOON WAS TOO LARGE TO REMOVE WITHOUT DAMAGING ANOTHER ARTERY. THEREFORE, BDC HAD TO BE OVER DILATED AND RUPTURED IN ORDER TO REMOVE AND PULL IT OUR FROM THE GUIDING CATHETER AS IT WAS NOTED THE BALLOON WOULD NOT FIT INTO THE GUIDING CATHETER WHEN INFLATED. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16303550 ↗
• MalfunctionJan 5, 2023Material Rupture; Improper or Incorrect Procedure or Method; Difficult to Advance; Material Rupture; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THAT THE 5X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS NOT SOAKED OR FLUSHED PRIOR TO USE. THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MILDLY TORTUOUS, 80% STENOSED LESION IN THE MID LEFT CIRCUMFLEX (MLCX) ARTERY. A 5X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITH RESISTANCE FROM THE NON-ABBOTT GUIDING CATHETER FOR POST-DILATATION OF AN IMPLANTED STENT. THE BDC WAS INFLATED ONE TIME TO 18 ATMOSPHERES (ATM) WHEN THE BALLOON RUPTURED DUE TO INTERACTION WITH THE NON-ABBOTT IMPLANTED STENT. A NEW SAME SIZE NC TREK BDC WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16108691 ↗
• DeathOct 20, 2022Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH PAIN AND THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) ARTERY AND THE LEFT MAIN (LM) ARTERY WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. TWO XIENCE SKYPOINTS WERE IMPLANTED IN THE LAD AND LM ARTERIES. THE NC TREK BALLOON DILATATION CATHETER (BDC) HAD NO RESISTANCE DURING ADVANCEMENT AND WAS USED FOR POST DILATATION PER STANDARD PROCEDURE, HOWEVER, A PERFORATION OCCURRED IN THE LAD. AN ADDITIONAL NON-ABBOTT STENT WAS USED TO TREAT THE PERFORATION. THE BALLOON WAS USED AGAIN FOR POST-DILATATION AND WAS FULLY DEFLATED (CONFIRMED BY X-RAY). HOWEVER, THE BALLOON WOULD NOT COME OUT OF THE GUIDE CATHETER. FORCE WAS APPLIED. ALL DEVICES WERE REMOVED TOGETHER AS A UNIT, HOWEVER, THE BALLOON SEPARATED FROM THE SHAFT AND GOT STUCK IN THE LM ARTERY. INTERVENTION WAS ATTEMPTED TO EMBED THE BALLOON BUT COULD NOT GET A GUIDEWIRE PAST THE BALLOON. THE PATIENT DIED. INTRAVASCULAR ULTRASOUND (IVUS) WAS USED AND THERE WAS NO THROMBUS. IN THE PHYSICIAN'S OPINION, THE NC TREK WAS PART OF THE REASON THAT CAUSED AND CONTRIBUTED TO THE DEATH, HOWEVER, THE 2 XIENCE SKYPOINT STENTS DID NOT CAUSE OR CONTRIBUTE TO THE DEATH. RETURNED DEVICE IDEN

  Patient problems: Perforation

  MAUDE report 15642849 ↗
• MalfunctionSep 2, 2022Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT THE TARGET LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE NC TREK DILATATION CATHETER WAS ADVANCED TO THE TARGET LESION VIA THE RIGHT RADIAL APPROACH. THE NC TREK WAS INFLATED TWICE TO NOMINAL PRESSURE AND DEFLATED WITHOUT ISSUE. THE NC TREK WAS REMOVED; HOWEVER, RESISTANCE WAS NOTED. THE DEVICE FELT LIKE IT GOT "HUNG UP", BUT WAS ABLE TO BE REMOVED. IT WAS NOTED THAT THE BALLOON PORTION OF THE DEVICE SEPARATED, BUT REMAINED ON THE GUIDE WIRE AND IN THE GUIDE CATHETER. THE DEVICES WERE REMOVED AS A SINGLE UNIT AND NO PORTION OF THE SEPARATED DEVICE REMAINED IN THE PATIENT ANATOMY. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15353236 ↗
• InjuryAug 15, 2022Deflation Problem; Difficult to Remove; Material Separation; Deflation Problem; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MILDLY TORTUOUS, 99% STENOSED LESION IN THE LEFT MAIN (LM) ARTERY. A 5X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND INFLATED THREE TIMES. THE FIRST INFLATION WAS TO 10 ATMOSPHERES (ATM), AND THE SECOND AND THIRD INFLATIONS WERE TO 16 ATM. NEGATIVE WAS HELD FOR ALMOST ONE MINUTE HOWEVER THE BALLOON WAS VERY SLOW TO DEFLATE. THE BALLOON WOULD NOT RETRACT INTO THE GUIDE LINER. RESISTANCE WAS FELT DURING REMOVAL, AND THE SHAFT OF THE DEVICE SEPARATED INTO TWO PIECES WITH APPROXIMATELY 20CM OF THE SHAFT INSIDE THE PATIENT AND THE OTHER PART OF THE SHAFT HANGING OUT OF THE GUIDELINER. ADDITIONALLY, THE BALLOON SEPARATED INTO 2 PIECES. A BALLOON WAS USED TO TRAP THE SEPARATED PORTION OF THE SHAFT AND THE BALLOON IN THE GC AND THE BDC WAS PULLED BACK INTO THE RADIAL SHEATH. THE RADIAL SHEATH WAS THEN REMOVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15229850 ↗
• InjuryJul 28, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION. A 5X12MM NC TREK BALLOON SNAPPED IN THE CATHETER DURING THE PROCEDURE. ALL PARTS WERE ABLE TO BE SUCCESSFULLY REMOVED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15122746 ↗
• InjuryJul 20, 2022Difficult to Remove; Failure to Deflate; Difficult to Remove; Failure to Deflate

  IT WAS REPORTED THAT THE 5.00X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS PREPARED FOR USE WITHOUT ANY ISSUES. THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING ARTERY WITH MODERATE CALCIFICATION. THE BDC WAS ADVANCED TO THE TARGET LESION FOR POST DILATATION AND THE BALLOON WAS INFLATED ONE TIME TO 12 ATMOSPHERES(ATM); HOWEVER, THE BALLOON FAILED TO DEFLATE. THE INFLATED BALLOON WAS PULLED TO THE BRACHIAL ARTERY; HOWEVER, IT WAS UNABLE TO REMOVE ANY FURTHER, SO A NEEDLE WAS ADVANCED, DEFLATING THE BALLOON AND ENABLING REMOVAL OF THE BDC FROM THE PATIENT. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15070103 ↗
• InjuryJul 7, 2022Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, HEAVILY TORTUOUS, 80% RE-STENOSED STENT IN THE RIGHT CORONARY ARTERY (RCA). A 5X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS USED TO DILATATE THE LESION, HOWEVER DURING REMOVAL, THE BALLOON SHAFT SEPARATED INTO TWO PIECES AND THE SEPARATED PIECE REMAINED IN THE SHEATH. A GUIDE WIRE WITH AN UNSPECIFIED ARMADA BALLOON, WERE USED TO PIN THE SEPARATED PIECE OF THE BALLOON AND PULL IT OUT OF THE TIP OF THE SHEATH TO REMOVE IT WHILE MAINTAINING ACCESS WITH THE SHEATH. THE PROCEDURE WAS CONCLUDED AT THAT POINT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14952050 ↗
• MalfunctionJun 27, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE HEAVILY CALCIFIED AND TORTUOUS 90% STENOSED RIGHT CORONARY ARTERY (RCA). THE 5.0 X 12 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED; HOWEVER, RESISTANCE WAS NOTED AND THE BDC WAS UNABLE TO CROSS. RESISTANCE WAS NOTED DURING REMOVAL, RELATED TO THE VESSEL AND LESION. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A NON-ABBOTT STENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14837593 ↗
• InjuryMay 9, 2022Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Deflate; Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Deflate

  USER FACILITY MEDWATCH STATES: [PATIENT UNDERWENT SUCCESSFUL BALLOON ANGIOPLASTY AS WELL AS SHOCKWAVE LITHOTRIPSY ASSISTED ANGIOPLASTY AND EXPANSION OF HIS PRIOR STENTING UP WITH A 5.0 NON-COMPLIANT BALLOON AT HIGH PRESSURES. THE PROCEDURE WAS COMPLICATED BY INABILITY TO DEFLATE THE 5.0 NON-COMPLIANT BALLOON AND INABILITY TO RETRACT IT INTO THE GUIDE OUT OF THE CORONARY ARTERY. SURGERY TEAM WAS ULTIMATELY ABLE TO RUPTURE THE BALLOON WITH POOLING OF ALL EQUIPMENT OUT THROUGH THIS SHEATH IN THE GROIN WITH SOME DIFFICULTY. ON POST-OP IMAGING, THIS PATIENT HAD NO RESIDUAL VASCULAR COMPLICATION FROM MULTIPLE ATTEMPTS AT PUNCTURING THE CORONARY BALLOON FOR DEFLATION. THE PATIENT SUFFERED NO COMPLICATIONS FROM THIS PROCEDURE.] ADDITIONAL INFORMATION RECEIVED CONFIRMS THAT THE LESION LOCATION TREATED WAS THE PROXIMAL RIGHT CORONARY ARTERY THAT WAS 90% STENOSED. THE PROCEDURE INVOLVED A 5X12MM NC TREK BALLOON. THERE WAS NO RESISTANCE WHEN ADVANCING THE DEVICE TO THE LESION. CONTRAST MIX WAS 60/40. THE NC TREK WAS INFLATED 3 TIMES INFLATED BETWEEN 15-18 ATMOSPHERES. THE DEVICE WAS REPOSITIONED BETWEEN INFLATIONS. FOR DEFLATION, AT FIRST 5-8 SECONDS WERE HELD NEGATIVE BUT WHEN THE PHYSICIAN R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14342717 ↗
• MalfunctionMar 28, 2022Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CALCIFIED VESSEL IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR PROTECTIVE SHEATH OF A 5.0X12 MM NC TREK RX BALLOON DILATATION CATHETER (BDC) AND THE DEVICE WAS PREPARED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE. CONTRAST MIX WAS 50/50 CONTRAST/SALINE. THE BALLOON WAS INFLATED ONCE AT 18 ATMOSPHERES (ATMS) AND NEGATIVE WAS HELD 30-45 SECONDS. HOWEVER, THE BALLOON DID NOT DEFLATE AND CONTRAST MEDIA REMAINED INSIDE. THE BALLOON COULD NOT BE PULLED BACK THROUGH THE GUIDING CATHETER. THE GUIDING CATHETER AND GUIDE WIRES WERE REMOVED. THE GUIDE WIRES WERE REMOVED FROM THE GUIDING CATHETER AND THEN THE PHYSICIAN MANAGED TO GET THE BALLOON OUT ULTIMATELY DEFLATED. ANOTHER SAME SIZE NC TREK BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13928551 ↗
• MalfunctionFeb 9, 2022Deflation Problem; Difficult to Remove; Deformation Due to Compressive Stress; Deflation Problem; Difficult to Remove; Deformation Due to Compressive Stress

  SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, AFTER THE BALLOON WAS INFLATED AND DEFLATED, IT WOULDN'T COME OUT. PHYSICIAN STATED IT WAS POSSIBLY STUCK ON STENT STRUTS. WHEN HE WAS FINALLY ABLE TO PULL IT BACK OUT OF THE STENT AND TOWARDS THE GUIDE, IT WOULDN'T COME BACK INTO THE GUIDE. HE HAD TO REMOVE THE GUIDE WITH THE BALLOON FROM THE BODY. WHEN IT WAS OUT OF THE BODY, THE DISTAL PORTION OF THE BALLOON WAS OUTSIDE THE GUIDE AND APPEARED TO BE UNDER-DEFLATED. THAT'S WHY IT WOULDN'T GO INTO THE GUIDE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13499017 ↗
• MalfunctionJan 25, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT CORONARY ARTERY WITH MILD CALCIFICATION AND 90% STENOSIS. A DRUG ELUTING STENT WAS IMPLANTED AND THEN THE 5.0X12 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS USED FOR POST-DILATATION. THE BDC WAS INFLATED ONCE FOR 10 SECONDS TO 10 ATMOSPHERES AND IT RUPTURED. A NON-ABBOTT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13346491 ↗