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	07/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the cerebral embolization procedure, the subject guidewire was navigated together with a microcatheter.The tip of the subject guidewire broke and remained inside the microcatheter.The subject device was replaced, and the procedure was completed successfully.There was a surgical delay of 20 minutes due to the reported event.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
D4 expiration date: updated.D4 gtin: updated.H4 manufacturing date: updated.There are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.The reported event is covered in the device direction 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 guidewire distal tip broken/fractured during use was unable to be confirmed and it cannot be confirmed that the device met specification, as the device was not returned.It was reported that during the cerebral embolization procedure, the subject guidewire was navigated together with a microcatheter.The tip of the subject guidewire broke, but it remained inside the microcatheter.The subject guidewire was removed was removed, a new guidewire was opened, and the procedure continued successfully.The additional information received indicates that continuous flush was set up and maintained throughout the clinical procedure, the patient's anatomy was moderately tortuous, there was tortuosity located proximal to the tip of the guidewire.The same microcatheter was used to complete the procedure.The device was not returned for analysis.Based on a review of all available information it is probable that the tortuosity experienced near the tip of the guidewire may have caused or contributed to the reported guidewire fracture.An assignable cause of procedural factors will be assigned to the reported guidewire distal tip broken/fractured during use, 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.
Event or Problem Description
It was reported that during the cerebral embolization procedure, the subject guidewire was navigated together with a microcatheter.The tip of the subject guidewire broke and remained inside the microcatheter.The subject device was replaced, and the procedure was completed successfully.There was a surgical delay of 20 minutes due to the reported event.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
D9 product available to stryker: updated.D9 returned to manufacturer on: updated.H3 device evaluated by mfg: updated.H11 additional mfg narrative: updated.There are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the subject guidewire was noted to be kinked and bent in a number of locations along its length.The distal 4.5 cm section of the subject guidewire was returned fractured and detached from the subject guidewire, there was kinking noted to the distal section.There was evidence of bending and damaging to the core wire and platinum coil to both the distal and proximal fracture locations.The functional inspection is not required as the guidewire had been fractured.The reported event is covered in the device direction 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 guidewire fracture was confirmed during the device analysis.The device failed to meet specifications when returned, based on the damage noted to the returned device.It was reported that during the cerebral embolization procedure, the subject guidewire was navigated together with the microcatheter.The tip of the subject guidewire broke, but it remained inside the microcatheter.The subject guidewire was removed, a new guidewire was opened, and the procedure continued successfully.The additional information received indicates that continuous flush was set up and maintained throughout the clinical procedure, the patient¿s anatomy was moderately tortuous, there was tortuosity located proximally to the tip of the guidewire.The same microcatheter was used to complete the procedure.The device was returned for analysis, and the distal tip of the guidewire was confirmed to be fractured and kinked, there was also additional kinking noted to the guidewire.It is probable that there were difficulties experienced during the delivery or manipulation of the guidewire, which may have caused the guidewire to kink and subsequently fracture.The patient¿s anatomy may have caused or contributed to the event.An assignable cause of procedural factors will be assigned to the reported and analysed event guidewire distal tip broken/fractured during use and to the analysed defect guidewire kinked/bent and guidewire distal end/tip kinked/bent , 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.
Event or Problem Description
It was reported that during the cerebral embolization procedure, the subject guidewire was navigated together with a microcatheter.The tip of the subject guidewire broke and remained inside the microcatheter.The subject device was replaced, and the procedure was completed successfully.There was a surgical delay of 20 minutes due to the reported event.No clinical consequences were reported to the patient due to this event.

• 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: 22636862
• Report Number: 3012931345-2025-00123
• Device Sequence Number: 7989888
• Product Code: MOF
• UDI-Device Identifier: 07613327508611
• UDI-Public: (01)07613327508611(17)270915(10)0000723574
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Followup
• Report Date (Section B): 12/16/2025

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: 0000723574
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/07/2025
• Supplement Date Received by Manufacturer: 09/19/2025; 11/25/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 10/06/2025; 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2024
• 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: EXCELSIOR SL-10 MICROCATHETER (STRYKER).
• Patient Age: 43 YR
• Patient Sex: Female