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

Model Number G30897

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

Patient Problem No Code Available (3191)

Event Date 10/09/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant products
=
philips pioneer catheter, 014 roadrunner, merit 5/6fr sheath. Reporter occupation
=
lab 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 an interventional procedure for a chronic total occlusion of the left superficial femoral artery, an advance 18 lp low profile balloon catheter ruptured and separated. The lesion was crossed using another manufacturer's catheter and the lesion was pre-dilated with a cook 2x6 18lp balloon. The complaint device was then inserted over a cook 0. 014 inch roadrunner wire guide. The balloon was inflated to approximately five or six atmospheres using a 50/50 ratio of omnipaque contrast to saline, at which point the balloon ruptured. The user then attempted to remove the balloon over the wire; however, it became stuck, possibly within the heavily calcified lesion, and separated. The sheath and balloon catheter were removed as a unit. The distal marker and separated portion of the balloon were left in the body, wrapped around the wire guide. A 6x13 cook performer sheath was then inserted and the user removed the separated portion of the device by pulling the wire guide and balloon fragment through the sheath. The patient did not require any additional procedures due to this occurrence. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• 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: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 10706673
• MDR Text Key: 212160857
• Report Number: 1820334-2020-01907
• 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: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 10/09/2021
• Device Model Number: G30897
• Device Catalogue Number: PTA4-18-80-4-20
• Device Lot Number: 9222176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2021
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2018
• 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: 10/20/2020 Patient Sequence Number: 1