MAUDE Adverse Event Report: COOK INC ADVANCE 18 LP LOW PROFILE BALLOON CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number G30970

Device Problems Fluid Leak (1250); Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/20/2020

Event Type  malfunction  

Manufacturer Narrative

Occupation: radiology tech. 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 an interventional procedure with atherectomy involving the right superficial femoral artery, a pinhole leak was found at the proximal end of an advance 18 lp low profile balloon catheter's balloon. The leak was found upon inflation of the device, which was being used for post dilation of an unknown stent. The balloon was inflated one time to ten atmospheres, using an 80/20 ratio of saline to omnipaque contrast, with an unknown inflation device. The lesion was reported to be approximately sixty percent occluded; however, no angulation, tortuosity, or calcification was noted. Blood was noted in the inflation device. Although a cook 6 french x 45-centimeter sheath was used during the procedure, the balloon was removed by itself, over an unknown wire guide. The procedure was successfully completed with another 18lp balloon. 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.

• Brand Name: ADVANCE 18 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: 10755560
• MDR Text Key: 214118217
• Report Number: 1820334-2020-01969
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130293
• 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: 02/03/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: G30970
• Device Catalogue Number: PTA4-18-150-7-20
• Device Lot Number: 13362132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2020
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial