MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL NANO 1MM X 3CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035431030
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/16/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the subject coil was used during coil embolization for subarachnoid hemorrhage (sah).Resistance was encountered when advancing the subject coil through the microcatheter and the coil was removed from the patient¿s body.The proximal section of the coil was found broken.Another coil was used to complete the procedure.There were no clinical consequences reported due to this event.
Event or Problem Description
It was reported that the subject coil was used during coil embolization for subarachnoid hemorrhage (sah).Resistance was encountered when advancing the subject coil through the microcatheter and the coil was removed from the patient¿s body.The proximal section of the coil was found broken.Another coil was used 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, the main coil was found kinked/bent and stretched but not broken.During functional testing, the main coil was advanced from the introducer sheath with resistance.In case of this complaint, no anomalies were noted to the device prior to use and there is no indication of a user error.The device is likely to have been damage during use resulting in the reported events.An assignable cause of procedural factor was assigned to the as reported issue 'nv coil in catheter friction' and to the as analyzed issues 'nv - main coil kinked/bent', 'nv main coil stretched', and 'nv coil introducer sheath friction', as the issues are associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.During analysis, it was confirmed that the main coil was not broken/fractured but it likely to have been perceived to be broken due to the stretching.An assignable cause of not confirmed was assigned to the as reported issue 'nv main coil broken/fractured'.The main coil was found kinked/bent and stretched but not broken.It is highly unlikely that the kinked/bent and stretched coil 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 1MM X 3CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8172200
• Report Number: 3008881809-2018-00536
• Device Sequence Number: 1697176
• Product Code: HCG
• UDI-Device Identifier: 04546540698018
• UDI-Public: 04546540698018
• 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): 02/12/2019

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: 03/31/2019
• Device Catalogue Number: M0035431030
• Device Lot Number: 19292524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2018
• Initial Date Received by Manufacturer: 11/20/2018
• Supplement Date Received by Manufacturer: 01/18/2019
• Initial Report FDA Received Date: 12/17/2018
• Supplement Report FDA Received Date: 02/12/2019
• 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: SL-10 MICROCATHETER(STRYKER)
• Patient Age: 49 YR
• Patient Weight: 74