MAUDE Adverse Event Report: COOK INCORPORATED COOK PTA5-25-80-7-4.0 ADVANCE; CATHETER, PERCUTANEOUS

Model Number G52352

Device Problem Material Rupture (1546)

Patient Problem Stenosis (2263)

Event Date 10/16/2018

Event Type  malfunction  

Event Description

Balloon angioplasty was being performed on left arm av fistula with tight stenosis.A.035 glidewire was advanced past the lesion.Balloon was advanced over the wire by physician.Balloon was slowly inflated over 2 minutes to burst pressure.Balloon ruptured circumferentially and fractured part of balloon had to be retrieved via cut-down procedure.Manufacturer response for balloon, cook (b)(4) (per site reporter): i will send info from the conversations between the radiologic practitioner assistant and cook.

• Brand Name: COOK PTA5-25-80-7-4.0 ADVANCE
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8037541
• MDR Text Key: 126102252
• Report Number: 8037541
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 10827002523521
• UDI-Public: (01)10827002523521
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G52352
• Device Catalogue Number: PTA5-35-80-7-4.0
• Device Lot Number: 9022362
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/24/2018
• Event Location: Hospital
• Date Report to Manufacturer: 11/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 21170 DA
• Patient Weight: 78