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

Catalog Number	M00326420
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Vasoconstriction (2126); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a hepatic arterial mapping case, distal tip of the subject guidewire was fractured during use and vasospasm was observed due to this event.The fractured piece of guidewire was successfully removed from the patient¿s body.The procedure was completed successfully with another device.The patient condition is detailed as fine.No further information is available.
Additional Manufacturer Narrative
H3 other text : the device is not available to the manufacturer.
Additional Manufacturer Narrative
There are controls in the manufacturing process to ensure the product met specifications upon release.The subject guidewire was not returned for analysis; therefore, physical as well as a functional testing could not be performed.The reported event is covered in the device direction 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 reported complaint was unable to be confirmed and it cannot be confirmed that the device met specification, as the subject guidewire was not returned.Additional information states that the patient suffered vasospasm as a result of the reported events.As the subject guidewire was not returned and a review of all available information fails to indicate an assignable cause, an assignable cause of undeterminable will be assigned to the as reported code 'guidewire distal tip broken/fractured during use¿.An assignable cause of anticipated procedural complication will be assigned to the reported code ¿patient vasospasm non-serious¿, as a product related root cause does not apply and the issue is due to a known physiological effect of the procedure and/or patient condition noted with the directions for use, product labeling and/or risk documentation files.
Event or Problem Description
It was reported that during a hepatic arterial mapping case, distal tip of the subject guidewire was fractured during use and vasospasm was observed due to this event.The fractured piece of guidewire was successfully removed from the patient¿s body.The procedure was completed successfully with another device.The patient condition is detailed as fine.No further information is available.

• Brand Name: SYNCHRO2-14 STANDARD 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: 19032210
• Report Number: 3012931345-2024-00052
• Device Sequence Number: 17897469
• Product Code: DQX
• UDI-Device Identifier: 04546540688774
• UDI-Public: 04546540688774
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2024

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: 06/23/2025
• Device Catalogue Number: M00326420
• Device Lot Number: 0000147437
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/12/2024
• Supplement Date Received by Manufacturer: 04/16/2024
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 05/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MICROCATHETER (UNKNOWN)
• Patient Age: 50 YR
• Patient Sex: Female