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

Model Number G50319

Device Problem Difficult to Remove (1528)

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

Event Date 01/27/2021

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, 4. 5fr sheath was inserted into the thrombotic occlusive lesion existing from the right popliteal artery to the posterior tibial artery. A right femoral artery approach was used. There was no angulation or vessel calcification noted. After passing through a 0. 014inch wire guide, the physician dilated the lesion with the reported advance 14 lp low profile balloon catheter (2mm × 20mm). For sizing-up of the balloon catheter, the physician tried to pull the reported balloon out of the sheath, but the balloon catheter was unable to be pulled out of the sheath. Therefore, the sheath and the reported balloon catheter were removed together. After that, a new 4. 5 fr sheath was inserted into the patient, and the physician used 2 advance14lp which were bigger sizes than the reported balloon catheter and dilated the lesion. The 2 advance14lp were removed from the patient's body without any problems. The procedure was completed without any problems. No adverse effects were reported due to this 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: 11273140
• MDR Text Key: 255111604
• Report Number: 1820334-2021-00243
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K170193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 05/12/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: G50319
• Device Catalogue Number: PTAX4-14-170-2-20
• Device Lot Number: 13303004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial