MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 7MM4CM 80; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number	4400704S
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot (82154911) 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, a powerflex pro pta balloon catheter (7mm4cm 80) was inflated after a non-cordis balloon catheter was inflated.However, it ruptured at 10-atmospheres pressure (atm) during its initial inflation.There was no reported patient injury.Therefore, the powerflex pro pta balloon catheter was replaced with a new non-cordis balloon catheter and the procedure was completed.The lesion was the left common femoral artery.The lesion had heavy stenosis and seemed to be heavily calcified.Initially, a contralateral approach was made from the right femoral artery with a non-cordis 6f guiding sheath and a non-cordis guidewire crossed the lesion.The device will be returned for analysis as the device was discarded in the hospital.
Additional Manufacturer Narrative
A powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter (7mm x 4cm x 80cm) was inflated after a non-cordis balloon catheter was inflated.However, it ruptured at ten atmospheres (atm) during its initial inflation.There was no reported patient injury.The lesion was the left common femoral artery.The lesion had heavy stenosis and seemed to be heavily calcified.Initially, a contralateral approach was made from the right femoral artery with a non-cordis 6f guiding sheath and a non-cordis guidewire crossed the lesion.The powerflex pro pta balloon catheter was replaced with a new non-cordis balloon catheter and the procedure was completed.The product was not returned for analysis.A product history record (phr) review of lot 82154911 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.However, vessel characteristics of heavy calcification and stenosis may have contributed to the reported event as calcification may damage balloon material.It is likely when attempting to cross the lesion, the balloon material may have encountered calcium damaging the balloon.However, without the return of the product or films of the procedure it is not possible to draw a clinical conclusion between the device and the 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/preventive action will be taken at this time.

• Brand Name: POWERFLEXPRO 7MM4CM 80
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 8679445
• Report Number: 9616099-2019-03000
• Device Sequence Number: 1644508
• Product Code: LIT
• UDI-Device Identifier: 20705032059692
• UDI-Public: 20705032059692
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K112797
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2019

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: 05/31/2021
• Device Catalogue Number: 4400704S
• Device Lot Number: 82154911
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2019
• Supplement Date Received by Manufacturer: 06/26/2019
• Initial Report FDA Received Date: 06/07/2019
• Supplement Report FDA Received Date: 06/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1