MAUDE Adverse Event Report: COOK INC ADVANCE 35 LP LOW PROFILE BALLOON CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number G35532

Device Problem Fluid Leak (1250)

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

Event Date 04/13/2021

Event Type  malfunction  

Manufacturer Narrative

Occupation: vascular surgery coordinator. Device evaluation has begun; however, a conclusion is not yet available. 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, during distal superficial femoral and popliteal artery revascularization, an advance 35 lp low profile balloon catheter leaked contrast. The device was used for post-stenting dilation of a stenosed lesion. The patient had no occlusion, angulation, or tortuosity. The balloon was in position before it was inflated with 25% contrast solution using an inflation device. Nominal pressure was not reached before the balloon started leaking. The balloon was then deflated and removed, while another manufacturer's device was used to complete the procedure. No portion of the device was left inside the patient. The patient did not require any additional procedures or prolonged hospitalization. There were no adverse effects due to this occurrence.

• Brand Name: ADVANCE 35 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 ; 8128294891
• MDR Report Key: 11760443
• MDR Text Key: 264791865
• Report Number: 1820334-2021-01271
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 08/04/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: G35532
• Device Catalogue Number: PTA5-35-135-5-20.0
• Device Lot Number: 13679036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial