MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL NANO 3 MM X 8 CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035453080
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/23/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.Visual examination of the returned device revealed that the main coil was physically detached from the delivery wire.The main coil was not returned.The investigation also found out that the coil delivery wire was kinked, likely due to handling damage during the clinical procedure.The 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 likely that damage was sustained to the device during the clinical procedure and that this contributed to the as reported event.As blood was noted on the device during analysis the main coil premature detachment was determined to have occurred inside the patient.Therefore, an assignable cause of operational context has been assigned to this investigation.
Event or Problem Description
Based on investigation of the returned product, the main coil detached prematurely inside the patient.There was no impact to the patient.

• Brand Name: TARGET HELICAL NANO 3 MM X 8 CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 6156461
• Report Number: 3008881809-2016-00299
• Device Sequence Number: 11019775
• Product Code: HCG
• UDI-Device Identifier: 07613252600442
• UDI-Public: (01)07613252600442(17)190131(10)18827994
• 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): 07/05/2016

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: 01/31/2019
• Device Catalogue Number: M0035453080
• Device Lot Number: 18827994
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2016
• Initial Report FDA Received Date: 12/08/2016
• 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)