MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL NANO 2.5 MM X 6 CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035452560
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/25/2017
Type of Reportable Event	Malfunction
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 broken and the main coil was kinked.Based on the information currently available, it is most likely that the delivery wire and the main coil were damaged due to handling of the device during the clinical procedure, or upon removal of the device from the packaging, or preparation of the device prior to use.Therefore an assignable cause of handling damage will be assigned to the delivery wire broken and main coil kinked.
Event or Problem Description
During the analysis of the returned device, it was revealed that the delivery wire was broken.No clinical consequences reported to the patient.

• Brand Name: TARGET HELICAL NANO 2.5 MM X 6 CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 6815513
• Report Number: 3008881809-2017-00268
• Device Sequence Number: 102960
• Product Code: HCG
• UDI-Device Identifier: 07613252600411
• UDI-Public: (01)07613252600411(17)190831(10)19232024
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• PMA/510(K) Number: K113412
• 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
• Report Date (Section B): 08/23/2017

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: 08/31/2019
• Device Model Number: M0035452560
• Device Catalogue Number: M0035452560
• Device Lot Number: 19232024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2017
• Initial Report FDA Received Date: 08/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1