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

Catalog Number	M0035431010
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/22/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the embolization procedure for the aneurysm at left pcoma (posterior communicating artery), the pusher wire of the coil was fractured inside the patient.So the physician withdraw the device and finished the procedure.No clinical consequence reported to the patient.
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.During the analysis of the returned device, it was revealed delivery wire was extremely kinked but had not broken.Therefore, the reported delivery wire broken was not confirmed.Even though the proximal contact wire was found broken during the analysis of the returned device, the proximal contact is not a contiguous part that forms the delivery wire, but is a subcomponent located 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 broken proximal contact may contribute 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.
Event or Problem Description
It was reported that during the embolization procedure for the aneurysm at left pcoma (posterior communicating artery), the pusher wire of the coil was fractured inside the patient.So the physician withdraw the device and finished the procedure.No clinical consequence reported to the patient.
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.During the analysis of the returned device, it was revealed that the delivery wire was kinked and fractured.In addition, the proximal contact was fractured as well.A probable cause of handling damage will be assigned to the reported and analyzed defects on the delivery wire and proximal contact, as the defect 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.
Event or Problem Description
It was reported that during the embolization procedure for the aneurysm at left pcoma (posterior communicating artery), the pusher wire of the coil was fractured inside the patient.So the physician withdraw the device and finished the procedure.No clinical consequence reported to the patient.

• Brand Name: TARGET HELICAL NANO 1MM X 1CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8903930
• Report Number: 3008881809-2019-00244
• Device Sequence Number: 19365039
• Product Code: HCG
• UDI-Device Identifier: 04546540700216
• UDI-Public: 04546540700216
• 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,Followup
• Report Date (Section B): 10/31/2019

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: 09/09/2021
• Device Catalogue Number: M0035431010
• Device Lot Number: 20860454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2019
• Initial Date Received by Manufacturer: 07/28/2019
• Supplement Date Received by Manufacturer: 09/12/2019; 10/21/2019
• Initial Report FDA Received Date: 08/16/2019
• Supplement Report FDA Received Date: 09/23/2019; 10/31/2019
• 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