MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO SELECT-14 STANDARD PS 215CM; GUIDE, WIRE, CATHETER, NEUROVASCULATURE

Catalog Number	SSTD215PRE
Medical Device Problem Codes	Fracture (1260); Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure after multiple attempts of passing the subject guidewire through the microcatheter, the distal tip of the subject guidewire broke and came out.There was a surgical delay of 15 min due to the reported event.No additional information available.
Event or Problem Description
It was reported that during the procedure after multiple attempts of passing the subject guidewire through the microcatheter, the distal tip of the subject guidewire broke and came out.There was a surgical delay of 15 min due to the reported event.No additional information available.Additional information received on 14-apr-2025 confirmed by the customer that the subject guidewire was broken during use outside the patient¿s body within the microcatheter hub.No additional information available.
Additional Manufacturer Narrative
B1 adverse event ¿ corrected ¿ no malfunction.B5 executive summary - updated.D9 product available to stryker: corrected.D9 returned to manufacturer on: updated.H1 type of reportable event: no malfunction.F10/h6 device code grid: corrected.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.

• Brand Name: SYNCHRO SELECT-14 STANDARD PS 215CM
• Common Device Name: GUIDE, WIRE, CATHETER, NEUROVASCULATURE
• 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: 21761920
• Report Number: 3012931345-2025-00071
• Device Sequence Number: 8490445
• Product Code: MOF
• UDI-Device Identifier: 07613327508512
• UDI-Public: (01)07613327508512(17)270428(10)0000655930
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K202522
• 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): 05/02/2025

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 Catalogue Number: SSTD215PRE
• Device Lot Number: 0000655930
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2025
• Supplement Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/29/2024
• 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: ECHELON MICROCATHETER (MEDTRONIC)
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 65 KG