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	Foreign Body In Patient (2687)
Date of Event	03/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3 other text : the device is not available to the manufacturer.
Event or Problem Description
It was reported that during a neurovascular procedure the subject guidewire tip fractured during use.The 1 cm fractured subject guidewire tip was left in the cavernous sinus; however, the place where the fractured subject guidewire tip remained was the space to fill with a coil.It was reported that the patients anatomy was severely tortuous.The subject guidewire was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Event or Problem Description
It was reported that during a neurovascular procedure the subject guidewire tip fractured during use.The 1 cm fractured subject guidewire tip was left in the cavernous sinus; however, the place where the fractured subject guidewire tip remained was the space to fill with a coil.It was reported that the patients anatomy was severely tortuous.The subject guidewire was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
H3 summary attached - updated.H3 device evaluated by mfg ¿updated.H4 manufacturing date ¿ added.D4 expiration date - added.D9 product available to stryker ¿ updated.D9 returned to manufacturer on ¿updated.There are controls in the manufacturing process to ensure the product met specifications upon release.Visual/microscopic inspection: the guidewire was seen to be kinked at 140cm.The guidewire was seen to be fractured at 213cm from the proximal end with the core and platinum wire exposed.Close to the guidewire distal tip end there seem to be an irregular shape/ damage.The distal tip fragment was not returned.Functional inspection: not required.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 complaint was confirmed based on analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.It was reported that while searching the route in cavernous sinus, it was confirmed that the distal tip did not follow when the subject guidewire was pulled.When the guidewire was removed, about 1 cm of the tip was fractured and remained in the cavernous sinus; however, the place where its remained was the space to fill with a coil.Additional information provided by the customer indicated that the device was confirmed to be in good condition during preparation/prior to use on the patient, continuous flush was set up and maintained throughout the clinical procedure and the patients anatomy was severely tortuous.The guidewire was returned and it was confirmed that the distal nitinol tubing and core wire had been fractured.There was kinking noted to the guidewire and some damage/deformation noted adjacent to the guidewire fracture site.It is probable that the guidewire was damaged as a result of the difficulties experienced trying to advance the guidewire through the patients anatomy, the damage noted is indicative of excessive forces being applied to the wire.An assignable cause of procedural factors will be assigned to the reported guidewire broken/fractured during use and un-retrieved device fragments and to the analyzed guidewire kinked/bent, guidewire distal tip damaged and 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.

• 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: 19102114
• Report Number: 3012931345-2024-00059
• Device Sequence Number: 7407679
• Product Code: MOF
• UDI-Device Identifier: 07613327508611
• UDI-Public: 07613327508611
• 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): 05/17/2024

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 Expiration Date: 04/15/2026
• Device Catalogue Number: SSUP215STR
• Device Lot Number: 250881
• 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: 03/28/2024
• Supplement Date Received by Manufacturer: 04/30/2024
• Initial Report FDA Received Date: 04/12/2024
• Supplement Report FDA Received Date: 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2023
• 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: ECHRON10 CATHETER (UNKNOWN).
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown