MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 8MM4CM 80; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 4400804S

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/12/2019

Event Type  malfunction  

Manufacturer Narrative

Additional information to include from facility name: social welfare corporation (b)(6) general hospital.Phone number: (b)(6).

Event Description

As reported, the 6mm x 10cm x 80 powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter (bc) ruptured at its approximate rated balloon pressure during its second inflation.There was no reported patient injury.The device was used as a post dilation after a smart stent was implanted.The lesion was the iliac artery.The device was replaced with another balloon catheter.The device will not be returned for evaluation because it was discarded.

Manufacturer Narrative

The 6mm x 10cm x 80 powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter (bc) ruptured at its approximate rated balloon pressure during its second inflation.There was no reported patient injury.The lesion was the iliac artery which was mildly calcified with vessel tortuosity.The percentage of stenosis was one hundred percent (100%).The device was used as a post dilation after a smart stent was implanted.The device was replaced with another balloon catheter.The device was stored and handled per the instructions for use (ifu).There was no difficulty removing the product from the hoop, the protective balloon cover, the stylet or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product into the patient.The device was prepped normally per the ifu.The same indeflator was used successfully with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve or guide catheter.There was no difficulty advancing the balloon catheter through the vessel or crossing the lesion.The balloon burst at approximately its rated burst pressure.The product was removed intact (in one piece) from the patient.Other additional procedural details were requested but were unknown.The product was not returned for analysis as it was discarded.A product history record (phr) review of lot 82160009 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.Vessel characteristics of calcification and a high rate of stenosis may have contributed to the reported event.Damage to balloon material may occur when attempting to cross a severely stenosed vessel that is calcified.However, without the return of the device for analysis, it is difficult to draw a clinical conclusion between the device and the event reported.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 (b)(4) of the balloons (with a (b)(4) 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 8MM4CM 80
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• MDR Report Key: 9440441
• MDR Text Key: 199106482
• Report Number: 9616099-2019-03392
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032059814
• UDI-Public: 20705032059814
• Combination Product (y/n): N
• PMA/PMN Number: K112797
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 01/06/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: 4400804S
• Device Catalogue Number: 4400804S
• Device Lot Number: 82160009
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/13/2019
• Initial Date FDA Received: 12/09/2019
• Supplement Dates Manufacturer Received: 12/11/2019
• Supplement Dates FDA Received: 01/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1