MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEX P3 F5 4X4 40; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4204040T
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the 5f 4mm x 4mm x 40cm powerflex p3 percutaneous transluminal angioplasty (pta) balloon catheter was used but it ruptured within its nominal pressure.Therefore, it was replaced with another non-cordis balloon catheter.There was no reported patient injury.This was a shunt pta case.The device will not be returned for evaluation because it was discarded at the hospital.
Additional Manufacturer Narrative
The 5f 4mm x 4mm x 40cm powerflex p3 percutaneous transluminal angioplasty (pta) balloon catheter was used but it ruptured within its nominal pressure.Therefore, it was replaced with another non-cordis balloon catheter.There was no reported patient injury.This was a shunt pta case.The product was not returned for analysis.A product history record (phr) review of lot 82206874 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, although unknown, may have contributed to the reported event as calcification is known to damage balloons.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.¿ neither the phr nor the very limited information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.

• Brand Name: POWERFLEX P3 F5 4X4 40
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 12091950
• Report Number: 9616099-2021-04671
• Device Sequence Number: 4898256
• Product Code: LIT
• UDI-Device Identifier: 20705032004098
• UDI-Public: 20705032004098
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K032737
• 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): 07/30/2021

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: 10/31/2023
• Device Model Number: 4204040T
• Device Catalogue Number: 4204040T
• Device Lot Number: 82206874
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/01/2021
• Supplement Date Received by Manufacturer: 07/08/2021
• Initial Report FDA Received Date: 06/30/2021
• Supplement Report FDA Received Date: 07/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK.