MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEX EXTREME 6X4 80CM; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4156040S
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for analysis but the engineering report is not yet available.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
A pinhole was noted on the balloon of 6mm x 4cm x 80cm powerflex extreme percutaneous transluminal angioplasty (pta) balloon catheter (bc).The balloon was removed intact and the procedure was completed with a non-cordis device.There was no reported patient injury.The device will be returned for analysis.
Additional Manufacturer Narrative
After further review of additional information received the following sections g4, g7, h2, h3 and h6 have been updated accordingly.A pinhole was noted on the balloon of 6mm x 4cm x 80cm powerflex extreme percutaneous transluminal angioplasty (pta) balloon catheter (bc).The balloon was removed intact and the procedure was completed with a non-cordis device.There was no reported patient injury.The product was returned for analysis.One non-sterile powerflex extreme 6 x 4 80cm balloon catheter was received for analysis coiled inside a plastic bag.Per visual analysis, the balloon had been previously inflated.Also, a kink was noted on the catheter body shaft at 6.7 cm from the distal tip end of the unit.Per microscopic analysis, the unit was inspected under the vision system and the previously mentioned kink was confirmed.No other anomalies were observed.Functional test was successfully performed.The unit was pre-inspected, and a syringe filled with water was attached to the guidewire lumen on the hub.The unit was properly flushed.Next, an additional insertion/ withdrawal test was done.A lab sample.035¿ guidewire was inserted/withdrawn through the guidewire lumen of the powerflex extreme.Then, a lab sample inflator-deflator was attached to the inflation lumen on the hub of the unit and positive pressure was applied.The balloon was successfully inflated.Neither a leakage nor any anomalies were observed.A product history record (phr) review of lot 82183780 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon leakage¿ could not be confirmed during device analysis.Functional analysis was performed, and the balloon successfully inflated with no anomalies noted to the device.The exact cause of the event reported could not be determined during analysis.The device performed as intended by successful inflation; therefore, it is likely that procedural factors and handling of the device, contributed to the event reported by the customer.According to the safety information in the instructions for use ¿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: POWERFLEX EXTREME 6X4 80CM
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 10503457
• Report Number: 9616099-2020-03892
• Device Sequence Number: 3055647
• Product Code: LIT
• UDI-Device Identifier: 20705032001752
• UDI-Public: 20705032001752
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K032737
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2020

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: 11/30/2022
• Device Model Number: 4156040S
• Device Catalogue Number: 4156040S
• Device Lot Number: 82183780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Initial Date Received by Manufacturer: 08/13/2020
• Supplement Date Received by Manufacturer: 09/11/2020
• Initial Report FDA Received Date: 09/08/2020
• Supplement Report FDA Received Date: 09/17/2020
• 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: UNKNOWN BALLOON CATHETER