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	05/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 other text : the subject device is unavailable to manufacturer.
Event or Problem Description
It was reported that during mca (middle cerebral artery) bifuration aneurysm embolization case, the operator used the subject guidewire to bring microcatheter to reach tail of m1 and then the operator found the subject guidewire lost its manipulation.The subject guidewire was withdrawn and found the tip 3-4cm was fractured.The subject guidewire was replaced with another guidewire to complete the procedure.There was no patient affected as a result of the event.No other information was provided.
Event or Problem Description
It was reported that during mca (middle cerebral artery) bifuration aneurysm embolization case, the operator used the subject guidewire to bring microcatheter to reach tail of m1 and then the operator found the subject guidewire lost its manipulation.The subject guidewire was withdrawn and found the tip 3-4cm was fractured.The subject guidewire was replaced with another guidewire to complete the procedure.There was no patient affected as a result of the event.No other information was provided.
Additional Manufacturer Narrative
D4 expiration date - added.D9 product available to stryker/ returned to manufacturer on - updated.H3 device evaluated by mfg ¿ updated.H4 manufacturing date ¿ added.There are controls in the manufacturing process to ensure the product met specifications upon release.Analysis of the returned subject guidewire device found the nitinol tubing of the subject guidewire was broken/fractured 209cm from the proximal end with the platinum coil broken and the core wire stretched but not broken.The subject guidewire was hydrated to activate the hydrophilic coating and there were no abnormal anomalies noted.The functional testing was not performed as the subject guidewire device was damaged.The event was confirmed based on the damage noted to the returned device.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.Additional information provided by the customer did not indicate any issues noted during unpacking or set up of the device, and the subject guidewire device was prepared as per dfu instructions.There was no indication of a user related issue.The anatomy was reported to be moderately tortuous.Other devices used in the procedure in conjunction with the subject guidewire device was microcatheter.In the physician¿s opinion, the cause of the fracture was the operator didn't do much manipulation to the subject guidewire, so he thought there was quality problem of it.There were no difficulties encountered during the usage of the subject guidewire device that could have contributed to the subject guidewire breakage.No resistance was encountered removing the subject guidewire from the dispenser hoop.A torque device was used to facilitate directional manipulation of the subject guidewire and there was no difficulty rotating the subject guidewire using the torque device.No excessive force was used during torqueing the subject guidewire.The guidewire was torqued 1 time.Analysis of the returned device found the nitinol tubing of the subject guidewire was broken/fractured 209cm from the proximal end with the platinum coil broken and the core wire stretched but not broken.The subject guidewire was hydrated to activate the hydrophilic coating and there were no abnormal anomalies noted.The damage to the subject guidewire indicates a force was used during the procedure.An assignable cause of procedural factors will be assigned to the as reported ¿catheter has difficulty tracking over guidewire¿ and ¿guidewire broken/fractured during use¿ and to the as analysed ¿guidewire broken/fractured during use¿ and ¿guidewire distal tip stretched' and 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: 19299753
• Report Number: 3012931345-2024-00085
• Device Sequence Number: 5665487
• Product Code: MOF
• UDI-Device Identifier: 07613327508611
• UDI-Public: 07613327508611
• 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): 07/02/2024

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 Expiration Date: 07/17/2026
• Device Catalogue Number: SSUP215STR
• Device Lot Number: 0000487223
• 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: 05/07/2024
• Supplement Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2023
• 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: SL10 MICROCATHETER
• Patient Sex: Unknown