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

Catalog Number	SSUP215STR
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during the thrombus retrieval as the subject guidewire was advanced to access the peripheral lesion, the distal tip of the guidewire fractured.Thrombus retrieval was continued, and and when suction was applied through the aspiration catheter, the fractured part of the subject guidewire was retrieved along with the thrombus.The procedure was completed successfully with no clinical consequences to the patient.
Additional Manufacturer Narrative
D9 product available to stryker ¿ updated.D9 returned to manufacturer on ¿updated.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 was noted to be kinked/bend to the proximal section.The distal end was noted to be broken along the nitinol tubing and the core and platinum wire at 209cm from the proximal end.The distal tip was noted to be shaped.The core wire distal end was observed through the distal tip dome.Functional testing was not carried out due to the damage noted to the device.The reported guidewire distal tip broken/fractured during use was confirmed during analysis.The reported device difficulty engaging target vessel could not be replicated; however, the analysis results are consistent with the reported event.The device failed to meet specification when returned for analysis.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, when the guidewire was about to be advanced further to access the peripheral lesion after lesion crossing, the distal tip of the guidewire fractured.Thrombus retrieval continued as normal, and when suction was applied through the aspiration catheter, the fractured part of the guidewire could be retrieved along with the thrombus.As per the additional information friction or resistance was encountered intravascularly, continuous flush was set up and maintained throughout the clinical procedure and the device was prepared for use as per the directions for use.The device was returned and it was confirmed that the distal end of the guidewire was fractured.It is likely that the device was fractured as a result of the friction/resistance encountered.An assignable cause of procedural factors will be assigned to the reported and analyzed damage of the guidewire distal tip broken/fractured during use and to the reported event of device difficulty engaging target vessel, as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.The proximal end of the guidewire was noted to be significantly kinked, it is likely that this occurred as a result of handling of the device during use or post procedure, therefore an assignable cause of handling damage will be assigned to the analyzed damage of the guidewire kinked/bent.
Event or Problem Description
It was reported during the thrombus retrieval as the subject guidewire was advanced to access the peripheral lesion, the distal tip of the guidewire fractured.Thrombus retrieval was continued, and when suction was applied through the aspiration catheter, the fractured part of the subject guidewire was retrieved along with the thrombus.The procedure was completed successfully with no clinical consequences to the patient.

• Brand Name: SYNCHRO SELECT-14 SUPPORT ST 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: 21355361
• Report Number: 3012931345-2025-00035
• Device Sequence Number: 18106401
• Product Code: MOF
• UDI-Device Identifier: 07613327508611
• UDI-Public: (01)07613327508611(17)270109(10)0000606861
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 05/06/2025

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: SSUP215STR
• Device Lot Number: 0000606861
• 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: 01/20/2025
• Supplement Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2024
• 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: PHENOM 21 CATHETER (UNKNOWN).
• Patient Sex: Unknown