MAUDE Adverse Event Report: COOK INCORPORATED ADVANCE; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number G35532

Device Problems Hole In Material (1293); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/23/2018

Event Type  malfunction  

Event Description

When balloon inflated in the vessel, balloon ruptured.Balloon was immediately removed from body.Vendor present.Stated balloon did not rupture, but product defective and hole in balloon.No harm to patient.

• Brand Name: ADVANCE
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7320008
• MDR Text Key: 101741797
• Report Number: 7320008
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: G35532
• Device Catalogue Number: PTA5-35-135-5-20.0
• Device Lot Number: 8255909
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/28/2018
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 02/28/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 94 YR