MAUDE Adverse Event Report: COVIDIEN AXIUM PLATINUM HELICAL; DETACHABLE COIL

Model Number QC-2-1-HELIX

Device Problem Separation Failure (2547)

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

Event Date 11/02/2014

Event Type  malfunction  

Event Description

Treatment of an aneurysm.On (b)(6) 2014, the patient underwent coiling embolization treatment.During the procedure, it was reported the implant coil could not be detached after it was placed in the aneurysm.No patient injury was reported as a result of the procedure.

Manufacturer Narrative

The device involved in the event has not been returned for evaluation.The lot history record of the reported lot number has been reviewed and no issues were noted that would have contributed to this event.

• Brand Name: AXIUM PLATINUM HELICAL
• Type of Device: DETACHABLE COIL
• Manufacturer (Section D): COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer Contact: 9775 toledo way; irvine, CA 92618 ; 9496801558
• MDR Report Key: 4300411
• MDR Text Key: 5268266
• Report Number: 2029214-2014-00709
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/06/2014

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: Health Professional
• Device Expiration Date: 05/17/2016
• Device Model Number: QC-2-1-HELIX
• Device Lot Number: 9749672
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/06/2014
• Initial Date FDA Received: 12/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 66