MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 8MM6CM 135; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number	4400806X
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot (17722781) 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, when a balloon dilation was performed with a powerflex pro pta balloon catheter (8mm6cm 135), it was found that the balloon was ruptured.There was no reported patient injury.The device will be returned for evaluation.
Additional Manufacturer Narrative
When a balloon dilation was performed with a powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter (8mm x 6cm x 135cm), it was found that that the balloon was ruptured.There was no reported patient injury.The device will be returned for evaluation.One product was returned for analysis.A non-sterile powerflexpro 8mm x 6cm x 135cm pta balloon catheter was returned.Per visual analysis, the balloon was coiled inside a plastic bag and the balloon was deflated.No anomalies were found.Functional analysis was performed, a lab sample syringe filled with water was attached to the luer hub of the catheter and successfully flushed.No resistance or loosen material/matter was observed during flushing procedure.An.035¿ guide wire sample was successfully introduced into the guide wire lumen of the balloon via tip all along through the unit with no obstruction noted.Lastly, a three-way valve was attached to the inflation lumen port, pressure was applied to inflate the balloon and no issues were noted.A product history record (phr) review of lot 17722781 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst¿ was not confirmed by analysis of the returned device as functional analysis was performed successfully the device inflated without anomalies.The exact cause of the reported event could not be determined.The device performed as intended; therefore, it is likely that handling and procedural factors contributed to 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 8MM6CM 135
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 8862210
• Report Number: 9616099-2019-03121
• Device Sequence Number: 525456
• Product Code: LIT
• UDI-Device Identifier: 20705032059845
• UDI-Public: 20705032059845
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K112797
• Number of Events Summarized: 1
• Summary Report (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): 08/26/2019

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: 09/30/2020
• Device Catalogue Number: 4400806X
• Device Lot Number: 17722781
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2019
• Supplement Date Received by Manufacturer: 08/07/2019
• Initial Report FDA Received Date: 08/05/2019
• Supplement Report FDA Received Date: 08/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1