MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 4MM X 15CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035424150
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/01/2016
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.Device visual and microscopic evaluation revealed that the main coil was found mechanically detached from the delivery wire.In addition, the main coil was found kinked and stretched; the introducer sheath, proximal contact, delivery wire were also kinked.A functional test was not performed due to the condition of the device.Information from the complaint indicated that the packaging was in good condition, and the bent proximal contact was found after unpacking and the device was not used in the procedure.It is possible that the observed damage to the coil occurred during handling of the device during and after unpacking.Therefore, an assignable cause handling damage has been assigned to this investigation.
Event or Problem Description
Analysis of the returned device revealed that the main coil was mechanically detached from the delivery wire.There was no patient involvement.
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.Further review of the analysis revealed that the main coil mechanically detached from the delivery wire.In addition the customer informed that the device became damaged while being removed from the hoop dispenser during preparation.Therefore, previously reported "premature deployment" is no longer applicable as the damage occurred during unpacking and not during use/inside the patient.The manufacturer has reviewed all information and determined this event no longer meets the requirement of a reportable event for the device in question.
Event or Problem Description
Analysis of the returned device revealed that the main coil was mechanically detached from the delivery wire.There was no patient involvement.

• Brand Name: TARGET 360 ULTRA 4MM X 15CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 6527227
• Report Number: 3008881809-2017-00133
• Device Sequence Number: 16558793
• Product Code: HCG
• UDI-Device Identifier: 04546540675941
• UDI-Public: (01)04546540675941(17)191031(10)19353484
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K112385
• 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
• Report Date (Section B): 06/13/2017

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: 10/31/2019
• Device Catalogue Number: M0035424150
• Device Lot Number: 19353484
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/29/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/27/2017
• Supplement Report FDA Received Date: 06/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1