MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-CALIF TARGET HELICAL NANO 1.5MM X 3CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035431530
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not returned.
Event or Problem Description
It was reported that during coil embolization procedure, the delivery wire of the coil was fractured when advanced through the microcatheter.The coil was replaced to complete the procedure.There were no clinical consequences reported due to this event.
Event or Problem Description
It was reported that during coil embolization procedure, the delivery wire of the coil was fractured when advanced through the microcatheter.The coil was replaced to complete the procedure.There were no clinical consequences reported due to this event.
Additional Manufacturer Narrative
The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.During visual inspection, it was found that the proximal contact was detached/separated at the proximal contact bond.The delivery wire was kinked/bent but not broken.In case of this complaint, the reported issue was not confirmed based on analysis as it was found that the delivery wire was not broken/fractured but that being said, the proximal contact was detached/separated, and this may have been perceived as being broken.The physician may have reported that the defect incorrectly.Because this complaint appears to be associated with handling of the product or portion of the product during the procedure/upon removal of the product from the packaging/preparation of the product prior to use, a probable cause of handling damage was assigned to the as reported and as analyzed issues 'nv - coil proximal contact detached/separated' and 'nv - coil delivery wire kinked bent.' the proximal contact is not a contiguous part that forms the delivery wire but is a subcomponent location at the proximal end of the delivery wire that works in conjunction with the inzone detachment system, and it remains outside the patient at all times during the procedure.It is highly unlikely that the detached/separated proximal contact may contributed to and/or cause any patient injury; the manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.

• Brand Name: TARGET HELICAL NANO 1.5MM X 3CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR-CALIF; 47900 bayside parkway; model farm road; fremont CA 94538
• MDR Report Key: 8215660
• Report Number: 3008881809-2019-00009
• Device Sequence Number: 19362615
• Product Code: HCG
• UDI-Device Identifier: 04546540698049
• UDI-Public: 04546540698049
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K153658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2019

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: 11/30/2020
• Device Catalogue Number: M0035431530
• Device Lot Number: 20139953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2019
• Initial Date Received by Manufacturer: 12/17/2018
• Supplement Date Received by Manufacturer: 02/13/2019
• Initial Report FDA Received Date: 01/03/2019
• Supplement Report FDA Received Date: 03/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EXCELSIOR SL-10 MICROCATHETER (STRYKER)
• Patient Age: 73 YR
• Patient Weight: 72