MAUDE Adverse Event Report: CORDIS CASHEL SABER RX2MM4CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 51002004L

Device Problems Balloon (419); Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2019

Event Type  Malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 17661083 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, a 2mmx4cm 155 saber rapid exchange (rx) percutaneous transluminal angioplasty (pta) balloon catheter (bc) was inserted and inflated to the right posterior tibial artery (rpta), however, it ruptured at approximately 10 atmospheres (atm) during its second inflation. Therefore, it was replaced with a new same size non-cordis balloon catheter and the procedure was completed. There was no reported patient injury. The device will not be returned for evaluation as it was discarded. The target lesion was the right posterior tibial artery and the popliteal artery. The lesion had severe calcification and stenosis. An ipsilateral approach was made with a non-cordis guiding sheath. A non-cordis micro-catheter and a non-cordis guidewire were able to cross the lesion. A non-cordis balloon catheter was inserted and inflated for the popliteal artery.

• Brand Name: SABER RX2MM4CM155
• 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: 9532372
• MDR Text Key: 199865881
• Report Number: 9616099-2019-03442
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (Y/N): N
• Reporter Country Code: JA
• 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: 01/26/2020

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 12/30/2019
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 03/31/2020
• Device MODEL Number: 51002004L
• Device Catalogue Number: 51002004L
• Device LOT Number: 17661083
• 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: 01/17/2020
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 04/04/2017
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial