MAUDE Adverse Event Report: COOK INC ADVANCE 18 LP LOW PROFILE BALLOON CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number G34339

Device Problems Material Rupture (1546); Material Separation (1562)

Patient Problems Thrombus (2101); Foreign Body In Patient (2687); No Code Available (3191)

Event Date 02/26/2020

Event Type  Injury  

Manufacturer Narrative

Initial reporter occupation
=
office manager. (b)(4). This report includes information known at this time. A follow-up report will be submitted should additional relevant information become available.

Event Description

As reported, during a revascularization procedure of the superficial femoral artery, an advance 18 lp low profile balloon catheter ruptured circumferentially at 22 atmospheres. A cook sphere inflation device was used to inflate the balloon one time with a 50/50 ratio of omnipaque contrast. The 70% stenosed lesion was at the origin of a previous superficial femoral-popliteal bypass anastomosis. No calcification or tortuosity was reported. The balloon was unable to be removed by itself; therefore, the balloon was removed together with a 5 french 45 centimeter ansel sheath and unknown wire guide. After removal, the user realized that the distal one-third of the balloon had separated, and part of the balloon was left in the patient. Blood was noted in the inflation device as the device was withdrawn. The balloon was not inflated within a stent prior to rupture. The patient reportedly presented to the emergency room the following day with a thrombus "cold leg". Emergency surgery was performed. Additional information has been requested, but is unavailable at this time.

• Brand Name: ADVANCE 18 LP LOW PROFILE BALLOON CATHETER
• Type of Device: LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 9834960
• MDR Text Key: 196399282
• Report Number: 1820334-2020-00614
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130293
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 09/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 11/07/2021
• Device Model Number: G34339
• Device Catalogue Number: PTA4-18-150-7-4
• Device Lot Number: 9294400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2020
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 03/16/2020 Patient Sequence Number: 1