MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL NANO 2 MM X 3 CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035452030
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/03/2017
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.Only the delivery wire was returned without the coil.Visual examination of the returned device revealed that target coil delivery wire was kinked/bentlikely due to handling.In addition, the main coil appeared to have physically detached from the delivery wire.Functional testing could not be performed on the returned device due to the condition in which it was returned.Follow up attempts were made to the customer to obtain additional information associated with the returned device; however, no further information is available.Information available indicated that the coil could not be advanced through the microcatheter (unknown manufacturer).Based on the information available and analysis of the returned device, the exact cause for the observed detachment of the coil from the delivery wire cannot be determined.
Event or Problem Description
Based on the analysis of the device, it was found that the main coil was physically detached from the delivery wire.There were no reported patient consequences.

• Brand Name: TARGET HELICAL NANO 2 MM X 3 CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7177422
• Report Number: 3008881809-2018-00028
• Device Sequence Number: 11114565
• Product Code: HCG
• UDI-Device Identifier: 07613252600367
• UDI-Public: (01)07613252600367(17)200430(10)19706311
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/09/2018

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: 04/30/2020
• Device Model Number: M0035452030
• Device Catalogue Number: M0035452030
• Device Lot Number: 19706311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2017
• Initial Report FDA Received Date: 01/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1