MAUDE Adverse Event Report: CORDIS CASHEL AVIATOR PLUS .014 4.0X30 142CM CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number 4244030W

Device Problem Burst Container or Vessel (1074)

Patient Problem Not Applicable (3189)

Event Date 09/25/2018

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 17661314 presented no issues during the manufacturing process that can be related to the reported event. This device is available for analysis but the engineering report is not yet available. However, it will be submitted within 30 days upon receipt.

Event Description

As reported, the. 014 4. 0x30 142cm aviator plus balloon was inserted and inflated for a post dilation during a coronary artery stent (cas) case. However, it ruptured. No patient injury was reported. The procedure was completed with a new unknown balloon catheter.

• Brand Name: AVIATOR PLUS .014 4.0X30 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: 7990276
• MDR Text Key: 124553867
• Report Number: 9616099-2018-02452
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 11/05/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 03/31/2020
• Device Catalogue Number: 4244030W
• Device Lot Number: 17661314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial