MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO-14 STRAIGHT 300-35CM; WIRE, GUIDE, CATHETER

Catalog Number	M00313310
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There are controls in the manufacturing process to ensure the product met specifications upon release.The subject guidewire device is not available; therefore, a visual inspection as well as a functional evaluation could not be performed.The reported events could not be 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.It was reported that, used a balloon catheter to dilate and stent to implant.Used guidewire 3m to deliver balloon catheter device to the stenosis and after dilation the operator withdrew the balloon, and the tip of the subject guidewire was found to be fractured.Used a solitaire ab stent to catch it but failed.Finally, the operator deployed the solitaire ab stent at the stenosis(also fixed the fractured guidewire) to finish the implantation.Additional information provided by the customer states that the device was confirmed to be in good condition during preparation/prior to use on the patient, continuous flush was set up and maintained throughout the clinical procedure and the patients anatomy was moderately tortuous.As the device was not returned and a review of all available information fails to indicate an assignable cause for the reported event, an assignable cause of undeterminable will be assigned to this complaint.
Event or Problem Description
It was reported that during left va v4 stenosis case, the balloon catheter was used to dilate and stent to implant.The guidewire 3m was used to deliver the balloon catheter to the stenosis, and after dilation the balloon catheter was withdrawn, as the tip of the subject guidewire was found to be fractured.Used a solitaire ab stent to catch it but unsuccessful.Finally, the operator deployed the solitaire ab stent at the stenosis (also fixed the fractured guidewire) to finish the implantation without clinical consequences to the patient.The current condition of the patient is normal.

• Brand Name: SYNCHRO-14 STRAIGHT 300-35CM
• 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: 20699172
• Report Number: 3012931345-2024-00200
• Device Sequence Number: 3757033
• Product Code: DQX
• UDI-Device Identifier: 07613252186946
• UDI-Public: (01)07613252186946(17)260220(10)0000624897
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K002907
• 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
• Report Date (Section B): 11/15/2024

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: 02/20/2026
• Device Catalogue Number: M00313310
• Device Lot Number: 0000624897
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2024
• Initial Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/22/2024
• 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: GATEWAY BALLOON CATHETER (STRYKER); SL-10 MICROCATHETER (STRYKER); SOLITARE AB STENT; SYNCHRO GUIDEWIRE 3M (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown
• Patient Race: Asian