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

Model Number QC-9-30-HELIX

Device Problems Stretched (1601); Failure to Disconnect (2541)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/30/2014

Event Type  malfunction  

Event Description

On (b)(6) 2014, the patient underwent coiling embolization treatment.During the procedure, it was reported the implant coil could not be detached.The implant coil was removed and it was found to be stretched.Another implant coil was used to successfully complete the procedure.No injury was reported as a result of the procedure.

Manufacturer Narrative

The pusher assembly was returned for evaluation with the implant coil still attached.The evaluation could not determine the cause of the event as the implant coil detached via the manual method (breaking of the hypotube, an alternative detachment method presented in the instructions for use); however, the pushwire and detachment stick were found bent and may have contributed to the reported event.All devices are 100% inspected for damages and irregularities during manufacture.The lot history record of the reported lot number has been reviewed and no issues were noted that would have contributed to this event.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).

• 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: 4298878
• MDR Text Key: 5197072
• Report Number: 2029214-2014-00705
• 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,Followup,Followup
• Report Date: 12/02/2014

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: 03/09/2017
• Device Model Number: QC-9-30-HELIX
• Device Lot Number: 9880761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/02/2014
• Initial Date FDA Received: 12/04/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/05/2014; 02/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2014
• 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