MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO 2/14 200 CM SOFT PRESHAPED; WIRE, GUIDE, CATHETER

Catalog Number	M00326110
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device is not available to the manufacturer.
Event or Problem Description
It was reported that during a transarterial intracranial thrombectomy of the left mca (middle cerebral artery ), the physician was attempting to access the thrombus via the left carotid artery and the guidewire (subject device) was sheared within the microcatheter.The broken guidewire was in the bend of the aspiration catheter in the carotid artery and a carotid cutdown was performed to remove the guidewire.No further information is available.
Event or Problem Description
It was reported that during a transarterial intracranial thrombectomy of the left mca (middle cerebral artery), the physician was attempting to access the thrombus via the left carotid artery and the guidewire (subject device) was sheared within the microcatheter.The broken guidewire was in the bend of the aspiration catheter in the carotid artery and a carotid cutdown was performed to remove the guidewire.No further information is available.
Additional Manufacturer Narrative
Manufacturing date: added.Expiration date: added.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.The cause of the reported issue could not be definitively determined.

• Brand Name: SYNCHRO 2/14 200 CM SOFT PRESHAPED
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• MDR Report Key: 8242347
• Report Number: 3012931345-2019-00006
• Device Sequence Number: 2124960
• Product Code: DQX
• UDI-Device Identifier: 04546540688736
• UDI-Public: 04546540688736
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K053268
• 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): 02/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/26/2021
• Device Catalogue Number: M00326110
• Device Lot Number: 0000010603
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/21/2018
• Supplement Date Received by Manufacturer: 02/17/2019
• Initial Report FDA Received Date: 01/11/2019
• Supplement Report FDA Received Date: 02/18/2019
• 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: GUIDING SHEATH(TERUMO); MICROCATHETER(PENUMBRA); RETRIEVER(PENUMBRA)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR