MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO2-14 SOFT PRE-SHAPED 200CM; WIRE, GUIDE, CATHETER

Model Number	M00326110
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2021
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 procedure the subject guidewire fell apart from the tip in an intracranial artery.It was taken away successfully.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
D4 lot # - corrected from na to 0000066470.There are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the guidewire was returned broken in 3 segments (187cm proximal segment, 25cm distal segment and 10cm distal segment), an attempt appeared to have been made to shape the guidewire tip, the guidewire ptfe coating was noted to be peeling in multiple areas to 50cm from the proximal end, the proximal segment 187cm had been pulled out of the nitinol tubing and the core wire was exposed, the distal segment 25cm of nitinol tubing had no core wire exposed, the distal segment 10cm was noted to have core wire exposed, the core wire distal end was observed through the distal tip dome, and the hydrophilic coating was hydrated there were no anomalies noted.A functional test could not be confirmed as the device was damaged.The event was confirmed based on the damage noted to the returned device.The device failed to meet specification when returned for analysis.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.The device was returned broken in 3 segments ((187cm proximal segment, 25cm distal segment and 10cm distal segment) which indicates the device encountered significant torque during the procedure.An assignable cause of procedural factors will be assigned to the as reported ¿guidewire distal tip broken/fractured during use¿ and as analyzed ¿guidewire broken/fractured during use¿ as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.Analysis of the returned device also found the ptfe was peeling from the proximal end up to 50cm from the proximal end which indicates the ptfe encountered an interaction with another device.However, this cannot be confirmed as the torque device and the introducer sheath were not returned for analysis.Therefore, a cause of undeterminable has been assigned to the as analyzed 'guidewire ptfe coating peeling'.
Event or Problem Description
It was reported that during procedure the subject guidewire fell apart from the tip in an intracranial artery.It was taken away successfully.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

• Brand Name: SYNCHRO2-14 SOFT PRE-SHAPED 200CM
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• Manufacturer (Section G): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 12629469
• Report Number: 3012931345-2021-00167
• Device Sequence Number: 19133815
• Product Code: DQX
• UDI-Device Identifier: 04546540688736
• UDI-Public: 04546540688736
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2022

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: 06/23/2024
• Device Model Number: M00326110
• Device Catalogue Number: M00326110
• Device Lot Number: 0000066470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/29/2021
• Supplement Date Received by Manufacturer: 01/13/2022
• Initial Report FDA Received Date: 10/14/2021
• Supplement Report FDA Received Date: 01/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown