MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 9MM4CM 80; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number	4400904S
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot (17714272) 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 (9mm4cm 80) balloon catheter was inserted as a post dilation after a stent was implanted.However, the powerflex pro balloon catheter ruptured.There was no reported patient injury.The device will not be returned for analysis.The lesion was the iliac artery.As of note: ¿the physician commented that the issue might have occurred due to a hit with the edge of the stent¿.
Additional Manufacturer Narrative
A powerflex pro percutaneous transluminal angioplasty (pta) 9mm x 4cm x 80cm balloon catheter was inserted as a post dilation after a stent was implanted.However, the powerflex pro balloon catheter ruptured.There was no reported patient injury.The lesion was the iliac artery.As of note: ¿the physician commented that the issue might have occurred due to a hit with the edge of the stent¿.The product was not returned for analysis.A product history record (phr) review of lot 17714272 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon-burst¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Procedural issues such as the balloon material possibly hitting the edge of the stent may have contributed to the reported event.Damage to balloon material may occur when attempting to cross a lesion which already has a stent in place.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 9MM4CM 80
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 8260772
• Report Number: 9616099-2019-02648
• Device Sequence Number: 16565612
• Product Code: LIT
• UDI-Device Identifier: 20705032059937
• UDI-Public: 20705032059937
• 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): 02/11/2019

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: 08/31/2020
• Device Catalogue Number: 4400904S
• Device Lot Number: 17714272
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/25/2018
• Supplement Date Received by Manufacturer: 02/08/2019
• Initial Report FDA Received Date: 01/18/2019
• Supplement Report FDA Received Date: 02/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1