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

Model Number G50321

Device Problems Fluid Leak (1250); Leak/Splash (1354)

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

Event Date 11/11/2021

Event Type  malfunction  

Manufacturer Narrative

Occupation: inventory manager. A follow up report will be submitted should additional relevant information become available.

Event Description

As reported, during an angioplasty of the peroneal artery and using a advance 14 lp low profile balloon catheter, the balloon leaked due to a tear in the material. The balloon was never able to be inflated. Contrast could be seen coming from it after first attempting to inflate it. A pinhole was observed and was leaking through that. A 6 french 45cm ansel was utilized during the procedure, as well as an inflation device. The balloon was removed through the sheath. There was no tortuous or calcified anatomy noted. There was no blood noted in the inflation device. No unintended section of the device remained inside of the patient's body. No additional procedures were required due to the occurrence. No adverse effects 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: 12857614
• MDR Text Key: 282422394
• Report Number: 1820334-2021-02560
• 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: Health Professional,User Facility,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/09/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: G50321
• Device Catalogue Number: PTAX4-14-170-2.5-4
• Device Lot Number: 13982120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial