MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 8MM4CM 135; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4400804X
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 82218349 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the 8mm x 4cm x 135 powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter was used but it ruptured in the mid balloon segment before the pressure reached its nominal pressure.There was no reported patient injury.This was an endovascular therapy (evt) case.The product was stored properly according to the instructions for use (ifu).There was no difficulty removing the product from the hoop and/or removing the protective balloon cover.There was no difficulty removing the stylet or any of the sterile packaging components.No kinks or any other damages were noted on the device prior to inserting in the patient.The device was prepped properly and was able to maintain negative pressure.The intended lesion was in the iliac artery.The lesion had moderate calcification.The device was being used to treat a chronic total occlusion (cto).The vessel had tortuosity with an acute bend.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve.No resistance was noted while advancing through the guide catheter.The balloon catheter was advanced through the vessel without difficulty.Some difficulty was noted while crossing the lesion with the balloon.The balloon never did kink while being used.The inflation device that was used, was used successfully with other devices during the procedure.The balloon was removed from the patient intact (in one piece).The case was completed after the use of a different size balloon.The device will not be returned for evaluation because it was discarded at the hospital due to suspicious infectious disease.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: g4, h1, h2, h3 and h6 as reported, the 8mm x 4cm x 135 powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter was used but it ruptured in the mid balloon segment before the pressure reached its nominal pressure.There was no reported patient injury.This was an endovascular therapy (evt) case.The product was stored properly according to the instructions for use (ifu).There was no difficulty removing the product from the hoop and/or removing the protective balloon cover.There was no difficulty removing the stylet or any of the sterile packaging components.No kinks or any other damages were noted on the device prior to inserting in the patient.The device was prepped properly and was able to maintain negative pressure.The intended lesion was in the iliac artery.The lesion had moderate calcification.The device was being used to treat a chronic total occlusion (cto).The vessel had tortuosity with an acute bend.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve.No resistance was noted while advancing through the guide catheter.The balloon catheter was advanced through the vessel without difficulty.Some difficulty was noted while crossing the lesion with the balloon.The balloon never did kink while being used.The inflation device that was used, was used successfully with other devices during the procedure.The balloon was removed from the patient intact (in one piece).The case was completed after the use of a different size balloon.The product was not returned for analysis as it was discarded at the hospital due to suspicious infectious disease.A product history record (phr) review of lot 82218349 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst - at/below rbp¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics of moderate calcification, vessel tortuosity and a chronically occluded lesion may have contributed to the reported event.It is likely upon attempt to cross or upon inflation, damage to balloon material occurred.However, without the return of the product for analysis, it is difficult to draw a clinical conclusion between the device and the reported event.According to the safety information in the instructions for use ¿if resistance is met during manipulation, determine the cause of the resistance before proceeding.Balloon pressure should not exceed the rated burst pressure.The rated burst pressure is based on the results of in vitro testing.At least 99.9% of the balloons (with a 95% confidence), will not burst at or below their rated burst pressure.Use of a pressure monitoring device is recommended to prevent over pressurization.Use only the recommended balloon inflation medium.Never use air or any gaseous medium to inflate the balloon.Prior to angioplasty, the catheter should be examined to verify functionality and ensure that its size and shape are suitable for the specific procedure for which it is to be used.¿ neither the phr nor the information available suggests a design or manufacturing related cause for the reported event.Therefore, no corrective or preventive action will be taken at this time.

• Brand Name: POWERFLEXPRO 8MM4CM 135
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 12500424
• Report Number: 9616099-2021-04880
• Device Sequence Number: 11606999
• Product Code: LIT
• UDI-Device Identifier: 20705032059821
• UDI-Public: (01)20705032059821(17)240331(10)82218349
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K112797
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: 4400804X
• Device Catalogue Number: 4400804X
• Device Lot Number: 82218349
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/26/2021
• Supplement Date Received by Manufacturer: 09/23/2021
• Initial Report FDA Received Date: 09/20/2021
• Supplement Report FDA Received Date: 09/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1