MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO2-14 SUPPORT PRE-SHAPED 215CM; WIRE, GUIDE, CATHETER

Model Number	S2SPP14215
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Subject device not available.
Event or Problem Description
It was reported that during procedure, the physician was going to implant a stent over a guidewire distal part (subject device) and the guidewire broke off in the basilar artery in the patient.The physician snared the piece of guidewire that was broken off.The procedure was not completed.There were no clinical consequences to the patient.
Additional Manufacturer Narrative
B3: event date: corrected.B5: executive summary: updated.D4: expiration date: updated.H4: manufacturing date: updated.Due to the automated mes system (manufacturing execution system), there are controls in the manufacturing process to ensure the product met specifications upon release.The reported defect was not confirmed and it cannot be confirmed that the device met specification as the device was not returned.The reported event is covered in the device directions for use (dfu).As well, 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.As the product was not returned and review and analysis of all available information fails to indicate an assignable cause or probable assignable cause for the reported event, an assignable cause of undeterminable will be assigned.
Event or Problem Description
It was reported that during procedure to treat a to treat basilar stenosis, the physician was going to implant a stent over a guidewire distal part (subject device) and the guidewire broke off in the basilar artery in the patient.The physician successfully snared the distal piece of guidewire that broke off.The stenting procedure was aborted.The patient was in stable condition.

• Brand Name: SYNCHRO2-14 SUPPORT PRE-SHAPED 215CM
• 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: 9668879
• Report Number: 3012931345-2020-00017
• Device Sequence Number: 2800493
• Product Code: DQX
• UDI-Device Identifier: 07613327459654
• UDI-Public: 07613327459654
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/07/2020

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: 08/04/2022
• Device Model Number: S2SPP14215
• Device Catalogue Number: S2SPP14215
• Device Lot Number: 0000030833
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/29/2020
• Supplement Date Received by Manufacturer: 04/30/2020
• Initial Report FDA Received Date: 02/04/2020
• Supplement Report FDA Received Date: 05/07/2020
• 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: WINGSPAN STENT SYSTEM (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention