MAUDE Adverse Event Report: CORDIS CASHEL AVIATOR PLUS .014 6.0X20 142CM CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 4246020W

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/26/2019

Event Type  Malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 17623155 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

During a carotid artery stent implantation, a. 014 6. 0x20 142cm aviator plus percutaneous transluminal angioplasty (pta)balloon catheter was attempted to be used for post-dilatation but it was found that there was a pinhole rupture at the tip of the balloon. The hole was noted after the packaging was opened, and the device was flushed. The device had been connected to the negative pressure pump. The device was not used and the procedure was completed using another balloon catheter. There was no reported patient injury. There were no difficulties removing the stylet or any of the sterile packaging components, the product from the hoop, or the protective balloon cover. There were no kinks or other damages noted prior to use. Iopamidol contrast media was used with a1:1, contrast to saline ratio. A non-cordis indeflator was used and it was used successfully with the other devices. Other additional procedural details were requested but were unknown.

• Brand Name: AVIATOR PLUS .014 6.0X20 142CM
• 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: 9511506
• MDR Text Key: 199695932
• Report Number: 9616099-2019-03427
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (Y/N): N
• Reporter Country Code: CH
• PMA/PMN Number: K071189
• 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,Followup
• Report Date: 01/30/2020

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 12/23/2019
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 11/30/2019
• Device MODEL Number: 4246020W
• Device Catalogue Number: 4246020W
• Device LOT Number: 17623155
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 12/27/2019
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/14/2020
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 01/27/2017
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial