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

Catalog Number	S2SPP14215
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a procedure, the tip of the subject guidewire was broken and remained in the patient.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.Visual and functional inspections were not performed due to 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.The reported issue could not be confirmed and it cannot be confirmed that the device met specification, as the device was not returned.It was reported that the tip of the guidewire was broken and remained in the patient.Additional information received indicated that this issue was noticed during use of the device on the patient, the device prepared for use as per the directions for use and the device was confirmed to be in good condition during preparation/prior to use on the patient.No further information was available.As the device was not returned an a review of all available information fails to indicate a probable 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 a procedure, the tip of the subject guidewire was broken and remained in the patient.No further information is available.

• 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
• 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: 19197260
• Report Number: 3012931345-2024-00064
• Device Sequence Number: 7658580
• Product Code: DQX
• UDI-Device Identifier: 07613327459654
• UDI-Public: 07613327459654
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 06/25/2024

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 Catalogue Number: S2SPP14215
• Device Lot Number: UNKNOWN
• 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: 04/18/2024
• Supplement Date Received by Manufacturer: 06/09/2024
• Initial Report FDA Received Date: 04/26/2024
• Supplement Report FDA Received Date: 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown