MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK F/G WINGSPAN STENT SYSTEM 4.0 X 15MM; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number	M003WS0400150
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during preparation for the procedure, the stent delivery wire broke.There were no reported clinical consequences to the patient.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.The subject device is not available; therefore, functional testing as well as physical analysis cannot be performed.Information available indicated that the device was damaged in error by the user.Based on the information currently available, an assignable cause of handling damage will be assigned to this event.
Event or Problem Description
It was reported that during preparation for the procedure, the stent delivery wire broke.There were no reported clinical consequences to the patient.

• Brand Name: F/G WINGSPAN STENT SYSTEM 4.0 X 15MM
• Common Device Name: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7779199
• Report Number: 3008881809-2018-00339
• Device Sequence Number: 13724320
• Product Code: NJE
• UDI-Device Identifier: 04546540722867
• UDI-Public: 04546540722867
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: H050001
• 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): 09/07/2018

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: 03/31/2019
• Device Catalogue Number: M003WS0400150
• Device Lot Number: 18967087
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/20/2018
• Supplement Date Received by Manufacturer: 09/04/2018
• Initial Report FDA Received Date: 08/13/2018
• Supplement Report FDA Received Date: 09/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1