MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 6MM12CM 135; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4400612X
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the balloon of 6mm 12cm 135 powerflex pro percutaneous transluminal angioplasty (pta) dilatation catheter ruptured at 7 atmospheres (atm), however, the nominal pressure was 10 atmospheres (atm).The device was stored and handled per the instructions for use (ifu).The device was prepped per the ifu.The target lesion was the superficial femoral artery.The device was not used for chronic total occlusion (cto).There was no difficulty removing the stylet or any of the sterile packaging components.There was no difficulty removing the product from the hoop.There was no difficulty removing the protective balloon cover.There were no kinks nor other damages noted prior to inserting the product into the patient.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve.There was no resistance/friction while inserting the balloon through the guide catheter.The catheter was never in an acute bend.No unusual force used at any time during the procedure.The product was removed intact (in one piece) from the patient.There was no patient injury.The device will not be returned in evaluation since it was discarded in the hospital.
Additional Manufacturer Narrative
Complaint conclusion: the balloon of a 6mm x 12cm 135cm powerflex pro percutaneous transluminal angioplasty (pta) dilatation catheter ruptured at seven atmospheres.The nominal pressure was ten atmospheres.There was no reported patient injury.The device was stored and handled per the instructions for use (ifu).There was no difficulty removing the stylet or any of the sterile packaging components.There was no difficulty removing the product from the hoop.There was no difficulty removing the protective balloon cover.The device was prepped per the ifu.The target lesion was the superficial femoral artery.The device was not used for chronic total occlusion (cto).There were no kinks nor other damages noted prior to inserting the product into the patient.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve.There was no resistance/friction while inserting the balloon through the guide catheter.The catheter was never in an acute bend.No unusual force used at any time during the procedure.The product was removed intact (in one piece) from the patient.The product was not returned for analysis.A product history record (phr) review of lot 82165489 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 product was not returned for analysis.The cause of the balloon burst could not be conclusively determined.Vessel characteristics, although unknown, may have contributed to the reported event, as calcification is known to cause damage to balloons.According to the instructions for use (ifu), which is not intended as a mitigation of risk, ¿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.¿ the information available does not suggest a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.

• Brand Name: POWERFLEXPRO 6MM12CM 135
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 9489603
• Report Number: 9616099-2019-03414
• Device Sequence Number: 19178607
• Product Code: LIT
• UDI-Device Identifier: 20705032059616
• UDI-Public: 20705032059616
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K112797
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2019

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: 12/31/2021
• Device Model Number: 4400612X
• Device Catalogue Number: 4400612X
• Device Lot Number: 82165489
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/19/2019
• Supplement Date Received by Manufacturer: 12/19/2019
• Initial Report FDA Received Date: 12/18/2019
• Supplement Report FDA Received Date: 12/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1