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

Model Number G30970

Device Problem Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/09/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter occupation: manager. 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, an advance 18 lp low profile balloon catheter ruptured. The target location was the left superficial femoral artery. An inflation device was used to inflate the balloon twice before rupturing on the second inflation to nominal pressure. The device was removed from the patient, and the procedure was completed with a new balloon. There was no delay in treatment. It was initially reported that no stent was used during the procedure, but information was later received that the balloon was inflated inside of a stent prior to the rupture. Clarification has been requested. A section of the device did not remain inside the patient. The patient did not require any additional procedures due to the occurrence. According to the initial reporter, the patient did not experience any adverse effects.

• 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: 14254858
• MDR Text Key: 290528761
• Report Number: 1820334-2022-00672
• 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: User Facility,Company Representative

Reporter Occupation

• Type of Report: Initial
• Report Date: 04/29/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: G30970
• Device Catalogue Number: PTA4-18-150-7-20
• Device Lot Number: 13728755
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial