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

Model Number G34325

Device Problems Material Rupture (1546); Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 10/15/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant products
=
cook kcfw-6. 0-35-55-rb-hfanl0-hc sheath, boston scientific v-18 control wire m00146850. (b)(4). 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, an advance 18 lp low profile balloon catheter ruptured and separated during an angiogram. The balloon was inflated one time, using an unknown inflation device, to eight atmospheres within the popliteal artery when it ruptured within thirty seconds. As the physician was pulling the balloon from the patient, it became caught on a 6 french cook sheath. Because the balloon was unable to be pulled through the sheath, the user removed the balloon, sheath, and other manufacturer's wire from the patient as a unit. A radiopaque marker remained visible on fluoroscopy after the device was removed. The marker, with a portion of the separated balloon material attached, was retrieved from the patient with a hemostat. A ct scan was performed and no additional balloon fragments were found in the patient. The anatomy was not angulated, tortuous or calcified. Blood was not noted in the inflation device. The balloon was not inflated within a stent. A counter-clockwise rotation of the device was not conducted upon removal. Initially, the user had intended to place a stent during the procedure, but elected to bring the patient back at a later date to do so. 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: 10726058
• MDR Text Key: 212723375
• Report Number: 1820334-2020-01924
• 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,user f

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: G34325
• Device Catalogue Number: PTA4-18-150-4-6
• Device Lot Number: 13202447
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 10/23/2020 Patient Sequence Number: 1