MAUDE Adverse Event Report: COVIDIEN (IRVINE) FRAMING COIL; DEVICE, EMBOLIZATION, VASCULAR

Model Number	FC-7-20-3D
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received and device evaluation anticipated, but not yet begun.Upon completion of the device evaluation a supplemental report will be filed.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that during coiling treatment of large left posterior communicating artery aneurysm, this coil detached prematurely inside the catheter.It was reported that physician experienced friction and difficulty with advancing the coil through the microcatheter.The coil got detached from the pushwire prior to the coil leaving the tip of microcatheter.The physician decided to remove the microcatheter along with the coil still inside the microcatheter.New coil and microcatheter were used and procedure completed successfully.No patient injury was reported.
Additional Manufacturer Narrative
The device was returned for evaluation.However, after analysis of the returned device the clinical observation could not be confirmed.As received, the implant coil was stretched but still attached to the pushwire within microcatheter.The tack weld replacement (twr) crimps and the pushwire distal to the break indicator at the manual detachment location (via hypotube) were found to be intact.Additionally, the pushwire was found bent at the proximal end and extending out from the rotating hemostatic valve (rhv).All other subassemblies appeared to be normal and no other anomalies were observed.It is likely that the implant coil became stretched due to the movement of the coil against the reported resistance.All devices are 100% inspected for damages and irregularities during manufacture.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: FRAMING COIL
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• MDR Report Key: 6504566
• Report Number: 2029214-2017-00468
• Device Sequence Number: 10895388
• Product Code: KRD
• UDI-Device Identifier: 00847536023031
• UDI-Public: 00847536023031
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K162704
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/12/2017

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: 12/15/2019
• Device Model Number: FC-7-20-3D
• Device Lot Number: A390267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2017
• Initial Date Received by Manufacturer: 03/27/2017
• Supplement Date Received by Manufacturer: Not provided; 05/12/2017
• Initial Report FDA Received Date: 04/19/2017
• Supplement Report FDA Received Date: 06/08/2017; 10/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1