MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO .010 WIRE SOFT STRAIGHT 300CM; WIRE, GUIDE, CATHETER

Catalog Number	M00316330
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported during treatment of a stroke, the distal end of the guidewire (subject device) broke off inside the patient.The physician removed the broken wire with a snare device and completed the procedure.No additional information is available.
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The reported issue is covered in the device directions for use.The risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.The device was not returned, so no visual inspection or functional testing was completed.Based on the information available, a cause of undetermined was assigned to this event.
Event or Problem Description
It was reported during treatment of a stroke, the distal end of the guidewire(subject device) broke off inside the patient.The physician removed the broken wire with a snare device and completed the procedure.No additional information is available.

• Brand Name: SYNCHRO .010 WIRE SOFT STRAIGHT 300CM
• 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: 8601822
• Report Number: 3012931345-2019-00044
• Device Sequence Number: 16714606
• Product Code: DQX
• UDI-Device Identifier: 07613252187165
• UDI-Public: 07613252187165
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K032146
• 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): 07/03/2019

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: 08/01/2021
• Device Catalogue Number: M00316330
• Device Lot Number: 0000012485
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/23/2019
• Supplement Date Received by Manufacturer: 06/20/2019
• Initial Report FDA Received Date: 05/10/2019
• Supplement Report FDA Received Date: 07/03/2019
• 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: MICROCATHETER (UNKNOWN MANUFACTURER)
• Outcome Attributed to Adverse Event: Required Intervention