MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL NANO 2 MM X 6 CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035452060
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/26/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.Analysis of the device revealed that the main coil was broken/ fractured from the delivery and the main coil was not returned.Information available indicated that the device was confirmed to be in good condition prior to use.Based on the information available and analysis of the device, it is probable that the device was damaged during the clinical procedure causing resistance and it is probable that the main coil was broken/ fractured from the delivery wire as a result.Therefore, an assignable cause of operational context has been assigned to this event.
Event or Problem Description
The analysis of the returned coil revealed that the delivery wire at the detachment zone was found to be broken.There was no clinical consequences to the patient reported.

• Brand Name: TARGET HELICAL NANO 2 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: 5727974
• Report Number: 3008881809-2016-00037
• Device Sequence Number: 23564
• Product Code: HCG
• UDI-Device Identifier: 07613252600381
• UDI-Public: (01)07613252600381(17)180731(10)18499021
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/26/2016

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: 07/14/2018
• Device Catalogue Number: M0035452060
• Device Lot Number: 18499021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2016
• Initial Report FDA Received Date: 06/15/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1