MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 6MM8CM 135; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4400608X
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 17398062 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 6mmx8cm 135 powerflex pro "balloon burst out of vessel".There was no patient injury reported.The device is expected to be returned for analysis.
Additional Manufacturer Narrative
A 6mm x 8cm x 135cm powerflex pro "balloon burst out of vessel".There was no patient injury reported.One product was returned for analysis.A non-sterile powerflex pro 6mm x 8cm x 135cm pta balloon catheter was returned.Per visual analysis, the balloon was coiled inside a plastic bag, no other anomalies were noted.Per functional analysis, a three-way valve was attached to the inflation lumen port, pressure was applied to the device to inflate the balloon and a leakage was observed.Per sem analysis, the outer surface of the balloon revealed evidence of scratch marks adjacent to the balloon rupture.Therefore, it can be assumed that mechanical damage due to a sharp object caused the condition on the balloon.A product history record review of lot 17398062 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 confirmed through analysis of the returned device.The exact cause of the burst could not be determined.Based on the limited information available for review, vessel characteristics (although unknown) may have contributed to the burst as evidenced by abrasions noted on the outer surface during analysis.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 or preventive action will be taken at this time.

• Brand Name: POWERFLEXPRO 6MM8CM 135
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 9123151
• Report Number: 9616099-2019-03226
• Device Sequence Number: 2413512
• Product Code: LIT
• UDI-Device Identifier: 20705032059562
• UDI-Public: 20705032059562
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 11/06/2019

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: 12/31/2018
• Device Model Number: 4400608X
• Device Catalogue Number: 4400608X
• Device Lot Number: 17398062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2019
• Initial Date Received by Manufacturer: 08/28/2019
• Supplement Date Received by Manufacturer: 10/24/2019
• Initial Report FDA Received Date: 09/26/2019
• Supplement Report FDA Received Date: 11/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1