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

Model Number PTA5-35-135-3-6.0

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/31/2019

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

It was reported the advance 35 lp low profile balloon catheter leaked during an unspecified angioplasty procedure involving a (b)(6) year-old female patient with a history of "arterial peripheral disease. " the balloon was properly introduced, with the distal tip reaching the injury site without complication. Reportedly, the lesion being treated was a non-occlusive stenosis with moderate calcification. As the physician began inflating the complaint device, the pressure on of the insufflator would not "hold", and slowly decreased. When the physician withdrew the device from the patient, the balloon was leaking form the proximal end, near the connection point between the balloon material and the shaft. 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 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: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 8796727
• MDR Text Key: 151764793
• Report Number: 1820334-2019-01710
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 10827002343754
• UDI-Public: (01)10827002343754(17)210122(10)8525861
• 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: health professional,user faci

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 09/11/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 01/22/2021
• Device Model Number: PTA5-35-135-3-6.0
• Device Catalogue Number: PTA5-35-135-3-6.0
• Device Lot Number: 8525861
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial