MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 7MM4CM 80; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 4400804X

Device Problem Burst Container or Vessel (1074)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/14/2022

Event Type  malfunction  

Manufacturer Narrative

As reported, the balloon of a 7mm x 4cm 80cm powerflex pro.035 percutaneous transluminal angioplasty (pta) balloon catheter ruptured during an inflation to nominal pressure.There was no reported injury to the patient.This was during an endovascular therapy (evt) procedure to treat an iliac lesion.The device was stored and prepped per the instructions for use (ifu) and maintained negative pressure during preparation.There was no difficulty removing the device from the hoop, removing the protective balloon cover, the stylet, or any of the sterile packaging components.The device was not kinked or damaged in any way prior to being inserted into the patient and there was no resistance or friction experienced during insertion.The device was able to track towards the lesion with ease; however, there was difficulty crossing the lesion and the device was put into an acute bend.The balloon catheter was able to be removed easily from the patient and remained in one piece during removal.Information regarding the patient, target vessel characteristics, contrast used, contrast to saline ratio, possible kinking of the device, and the completion of the procedure was requested but not provided.The product was not returned for analysis as it was discarded.A product history record (phr) review of lot 82235789 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, although unknown, may have contributed to the reported event.However, with the limited amount of information provided regarding lesion characteristics and 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 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.

Event Description

As reported, the balloon of a 7mm x 4cm 80cm powerflex pro.035 percutaneous transluminal angioplasty (pta) balloon catheter ruptured during an inflation to nominal pressure.There was no reported injury to the patient.This was during an endovascular therapy (evt) procedure to treat an iliac lesion.The device was stored and prepped per the instructions for use (ifu) and maintained negative pressure during preparation.There was no difficulty removing the device from the hoop, removing the protective balloon cover, the stylet, or any of the sterile packaging components.The device was not kinked or damaged in any way prior to being inserted into the patient and there was no resistance or friction experienced during insertion.The device was able to track towards the lesion with ease; however, there was difficulty crossing the lesion and the device was put into an acute bend.The balloon catheter was able to be removed easily from the patient and remained in one piece during removal.Information regarding the patient, target vessel characteristics, contrast used, contrast to saline ratio, possible kinking of the device, and the completion of the procedure was requested but not provided, and the device was discarded and will not be returned for evaluation.

Manufacturer Narrative

For section h6, the code of "4115 - device discarded" was added as a correction due to the fact that the device involved was discarded.  br.

• Brand Name: POWERFLEXPRO 7MM4CM 80
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 14088180
• MDR Text Key: 289667994
• Report Number: 9616099-2022-05537
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032059821
• UDI-Public: (01)20705032059821(17)241130(10)82235789
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112797
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/13/2022

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 Model Number: 4400804X
• Device Catalogue Number: 4400704S
• Device Lot Number: 82235789
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2022
• Initial Date FDA Received: 04/12/2022
• Supplement Dates Manufacturer Received: 03/15/2022
• Supplement Dates FDA Received: 04/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNK.