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

Model Number 4400804S

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/07/2019

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 82168672 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 Description

As reported, after an intravascular ultrasound (ivus), the user attempted to inflate the lesion using the 8mm 4cm 80 powerflex pro balloon catheter (bc), however, it ruptured at its nominal pressure during the initial inflation. Therefore, it was replaced with another device and the procedure was continued. There was no reported patient injury. The device was used during a percutaneous transluminal angioplasty (pta) case. The target lesion was the subclavian vein. A non-cordis guidewire crossed the stenosis part.

• Brand Name: POWERFLEXPRO 8MM4CM 80
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 9349993
• MDR Text Key: 198971172
• Report Number: 9616099-2019-03364
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032059814
• UDI-Public: 20705032059814
• 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: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/24/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 03/31/2022
• Device Model Number: 4400804S
• Device Catalogue Number: 4400804S
• Device Lot Number: 82168672
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial