MAUDE Adverse Event Report: COVIDIEN (IRVINE) BARE AXIUM 3D COIL; DEVICE, EMBOLIZATION, VASCULAR

Model Number	QC-25-50-3D
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The axium coil was not returned for analysis; therefore, no definitive conclusion can be drawn regarding the clinical observation.However, the device is pending return.Upon receipt of the device a supplemental report will be filed.
Event or Problem Description
Medtronic received information that during coiling treatment of an aneurysm located in the cavernous sinus, this coil would not detach with an instant detacher.It was reported that physician attempted to detach the coil 3 times with the instant detacher.The physician removed the device and found the coil to be stretched.A new device was used to complete the treatment successfully.No patient injury was reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Device evaluation: device evaluated by manufacturer- additional information: codes updated the device was returned for evaluation and the clinical observation could not be confirmed.As received the implant coil was found in good condition but already detached from the pushwire.The instant detacher was not returned.The pushwire was found broken and jagged on the proximal end with a broken release wire extending out.The pushwire was found intact distal to the break indicator at the manual detachment location (via hypotube).Additionally, the pushwire was found bent at the proximal end.Under the microscope, the coin was found pulled back from the lumen stop, and the shield coil was found damaged.The retainer ring appeared damaged and ovalized.The instant detacher and the proximal end of the pushwire containing the tack weld replacement (twr) crimp were not returned; therefore, any contributing factors from these could not be assessed.The customer reported they did not attempt to detach the implant coil via the manual method; therefore, the cause for the break in the pushwire with the release wire pulled back could not be determined.It is likely that the implant coil detached from the pushwire due to the coin pulling back from the lumen stop.It is possible that the break in the pushwire with a jagged edge may have led to the break in the release wire.All coils are 100% inspected for damages and irregularities during manufacture.Per the axium coil and i.D.(instant detacher) instructions for use (ifu): directions for use: if the coil does not detach after 3 attempts, discard the i.D.(instant detacher) and replace with a new i.D.(instant detacher).Also, in the rare event that the coil does not detach and cannot be removed from the implant delivery pusher, use the following steps for detachment.Grip the hypotube approximately 5 cm distal of the positive load indicator at the hypotube break indicator and bend the implant delivery pusher just distal to the hbi 180 degrees.Next straighten the pusher back, continue bending and straightening until the pusher tubing opens exposing the release element.Gently separate the proximal and distal ends of the open pusher.Then, under fluoroscopy, pull the proximal portion of the implant delivery pusher approximately 2-3 cm to confirm implant detachment per ifu.If information is provided in the future, a supplemental report will be issued.

• Brand Name: BARE AXIUM 3D COIL
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• MDR Report Key: 6406358
• Report Number: 2029214-2017-00186
• Device Sequence Number: 16222559
• Product Code: KRD
• UDI-Device Identifier: 00836462010543
• UDI-Public: 00836462010543
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K081465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/28/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/22/2018
• Device Model Number: QC-25-50-3D
• Device Catalogue Number: QC-25-50-3D
• Device Lot Number: A192337
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2017
• Initial Date Received by Manufacturer: 03/05/2017
• Supplement Date Received by Manufacturer: 06/28/2017; 06/28/2017
• Initial Report FDA Received Date: 03/15/2017
• Supplement Report FDA Received Date: 07/18/2017; 10/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR