MAUDE Adverse Event Report: COOK INC ADVANCE 14 LP LOW PROFILE BALLOON CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number G50333

Device Problems Material Puncture/Hole (1504); Material Rupture (1546)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/03/2021

Event Type  malfunction  

Manufacturer Narrative

Reporter occupation: head tech. 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 below the knee angioplasty, the balloon ruptured from a advance 14 lp low profile balloon catheter. A 6fr cook ansel 45cm sheath was also utilized during the procedure. The lesion was located in the posterior tibia with 90% occluded. The inflation device used was from another manufacturer. The balloon had been inflated at least two times and the duration of the inflations is unknown. The inflation pressure was unknown. There was blood noted in the inflation device. The contrast used for inflation was unknown. They were able to remove the device by removing the balloon over the wire. There was no angulation or vessel tortuosity noted, but there was vessel calcification due to a significant amount of calcified plague. The procedure was already completed prior to the device rupture. No unintended section of the device remained inside of the patient. No additional procedures were required due to this occurrence. No adverse effects to the patient were reported due to the occurrence.

• Brand Name: ADVANCE 14 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: 11297281
• MDR Text Key: 263154352
• Report Number: 1820334-2021-00282
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 05/10/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: G50333
• Device Catalogue Number: PTAX4-14-170-3-20
• Device Lot Number: 13524965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial