MAUDE Adverse Event Report: COOK MEDICAL, INC; BALLOON CATHETER

Catalog Number G26896

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/12/2014

Event Type  malfunction  

Event Description

Balloon separated from the catheter and retained in the patient.

• Type of Device: BALLOON CATHETER
• Manufacturer (Section D): COOK MEDICAL, INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 4619979
• MDR Text Key: 5587269
• Report Number: 4619979
• Device Sequence Number: 1
• Product Code: EZL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: G26896
• Device Lot Number: 4995601
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/12/2015
• Event Location: Hospital
• Date Report to Manufacturer: 03/20/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/12/2015
• Patient Sequence Number: 1
• Patient Age: 22 YR