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

Model Number G50322

Device Problem Fluid/Blood Leak (1250)

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

Event Date 10/21/2021

Event Type  malfunction  

Manufacturer Narrative

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, while prepping an advance 14 lp low profile balloon catheter, it was noted that the device was not filling with contrast. An inflation device was used. It appeared there might have been a hole somewhere. The procedure was successfully completed with another device of the same type. No unintended section of the device remained inside of the patient's body. No additional procedures were required due to this occurrence. No adverse effects were reported due to the alleged product malfunction.

• 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: 12751782
• Report Number: 1820334-2021-02438
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 10827002503226
• UDI-Public: (01)10827002503226(17)240525(10)13982123
• 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: User Facility,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: G50322
• Device Catalogue Number: PTAX4-14-170-2.5-6
• Device Lot Number: 13982123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/02/2023
• 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
• Patient Sex: No Answer Provided
• Patient Weight: KG