MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO SELECT-14 STANDARD ST 300CM; GUIDE, WIRE, CATHETER, NEUROVASCULATURE

Catalog Number	SSTD300STR
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the during aneurysm at the bifurcation of the left middle carotid artery (mca) procedure, the operator prepared to used the subject guidewire along with a microcatheter to prepare for superselective aneurysm catheterization.However, when shaping the subject guidewire before use, the operator noticed the coating at the distal end of the guidewire was peeling off.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
H3 device evaluated by mfg ¿updated there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection the guidewire tip was noted to be kinked/bent.The guidewire polytetrafluoroethylene (ptfe) coating was noted to be damaged at the proximal end and 14 to 18 cm from the proximal end.There were no anomalies noted to the distal hydrophilic coating.The core wire distal end was observed through the distal tip dome.Functional test was not conducted as the defect was visually confirmed.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 event ¿hydrophilic coating peeling¿ was not confirmed during analysis.The device failed to meet specification when returned for analysis.It was reported that when shaping the guidewire before use, the physician noticed the coating at the distal end of the guidewire was peeling off.The device was returned and it was noted that the distal end of the guidewire was kinked/bent, there was also peeling noted to the proximal ptfe coating.It is probable that the distal end of the guidewire was damaged during the attempt to shape the tip of the guidewire, however there was no damage noted to the hydrophilic coating.An assignable cause of not confirmed will be assigned to the reported event ¿hydrophilic coating peeling¿, as the issue included a returned product review (visual, physical, and/or performance testing) which showed no evidence of either the alleged issue(s) or any defect which could have contributed to the event.An assignable cause of handling damage will be assigned to the analysed event ¿guidewire distal end/tip kinked/bent¿, as it is likely that this occurred due to handling during the shaping attempt.It is probable that the ptfe coating was peeled due to interaction with the torque device, likely after the torque device was removed after use, therefore an assignable cause of handling damage will be assigned to the analysed event ¿guidewire ptfe coating peeling¿.
Event or Problem Description
It was reported the during aneurysm at the bifurcation of the left middle carotid artery (mca) procedure, the operator prepared to used the subject guidewire along with a microcatheter to prepare for superselective aneurysm catheterization.However, when shaping the subject guidewire before use, the operator noticed the coating at the distal end of the guidewire was peeling off.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: SYNCHRO SELECT-14 STANDARD ST 300CM
• 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: 21574800
• Report Number: 3012931345-2025-00057
• Device Sequence Number: 18377623
• Product Code: MOF
• UDI-Device Identifier: 07613327508505
• UDI-Public: (01)07613327508505(17)270916(10)0000723872
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 06/09/2025

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: SSTD300STR
• Device Lot Number: 0000723872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/20/2025
• Supplement Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2024
• 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: SL-10 MICROCATHETER (STRYKER).
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Race: Asian