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

Model Number G50333

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

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

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 using an advance 14 lp low profile balloon catheter, the balloon leaked. They gained vascular access by the knee. The user inflated the balloon and noted contrast had diffused. Then user removed the device and inflated the balloon outside the body. They then discovered the balloon had a leak. The device could not be inflated normally. The user changed a same device to finish the procedure. A section of the device did not remain inside the patient¿s body. 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. Additional patient and event information has been requested.

• 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: noah cross ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 11306913
• MDR Text Key: 258597549
• Report Number: 1820334-2021-00290
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K170193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 05/07/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/10/2021
• 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: 10071007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2021
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial