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

Model Number	SSTD215PRE
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During stryker internal r&d simulated use testing in a silicone model, operator noticed that the subject guidewire was not responding to torque applied.The operator pulled subject guidewire out of the model and found distal hypotube of subject guidewire fractured.The subject guidewire was used in a bench top flow model in a lab and there was no patient involvement.
Additional Manufacturer Narrative
H3 other text : the device is not available to the manufacturer.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added.H3 device evaluated by mfg ¿ updated.H3 summary attached - updated.D4 expiration date - added.D10 product available to stryker ¿ updated.D10 returned to manufacturer on ¿ updated.There are controls in the manufacturing process to ensure the product met specifications upon release.During visual/microscopic inspection, an attempt appeared to have been made to shape the tip of the guidewire.The guidewire was noted to be kinked/bent at 4.8cm from the proximal end.A further kink was noted at 6.7cm from the distal end.On further inspection the kink at the distal end was found to be broken/fractured.The nitinol tubing was broken/fractured, and the platinum coil was intact.The core wire was also noted to be intact.The core wire distal end was observed through the distal tip dome.The torque device was not returned.Functional inspection was not applicable as the guidewire was broken/fractured.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 event was confirmed based on the damage noted to the returned device.The device failed to meet specification when returned for analysis.Additional information provided by the customer indicated that they don¿t think any damage was noted to the packaging prior to opening the packaging or if any anomalies were noted to the device during initial inspection and preparation but was not inspected for these.They are unsure if the device was prepared as per the dfu, if the dispenser hoop was flushed before removing the guidewire, if any resistance was encountered removing the guidewire from the dispenser hoop, if continuous flush was maintained for the duration of the procedure or if friction/resistance was encountered during the procedure.The guidewire tip was shaped but they are not sure of the degree.The torque device was used with the guidewire.New bench top models were being evaluated.The issue with the guidewire was noted distal on the hypotube.Analysis of the returned device found the guidewire tip had been shaped.A kink/bend was noted 4.8cm from the proximal end.A further kink was noted 6.7cm from the distal end and on further inspection it was found to be broken/fractured.The nitinol tubing was broken/fractured but the platinum coil and core wire were both intact.The damage to the guidewire indicates a force was applied during removal of the device from the bench top model.It is probable that the device was fractured during use/removal from the bench top model causing the device to be un-responsive to torquing.An assignable cause of procedural factors will be assigned to the as reported ¿¿guidewire torque problem¿ and ¿guidewire distal tip broken/fractured during use¿ and to the as analyzed ¿guidewire kinked/bent¿ and ¿guidewire distal tip broken/fractured during use¿ 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.
Event or Problem Description
During stryker internal r&d simulated use testing in a silicone model, operator noticed that the subject guidewire was not responding to torque applied.The operator pulled subject guidewire out of the model and found distal hypotube of subject guidewire fractured.The subject guidewire was used in a bench top flow model in a lab and there was no patient involvement.

• Brand Name: SYNCHRO SELECT-14 STANDARD PS 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: 17008549
• Report Number: 3012931345-2023-00096
• Device Sequence Number: 7549562
• Product Code: MOF
• UDI-Device Identifier: 07613327508512
• UDI-Public: 07613327508512
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K202522
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2023

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: Other
• Device Expiration Date: 04/25/2025
• Device Model Number: SSTD215PRE
• Device Catalogue Number: SSTD215PRE
• Device Lot Number: 0000127369
• 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: 05/02/2023
• Supplement Date Received by Manufacturer: 08/14/2023
• Initial Report FDA Received Date: 05/26/2023
• Supplement Report FDA Received Date: 09/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2022
• 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: AXS CATALYST 5 DISTAL ACCESS CATHETER (STRYKER); AXS INFINITY LONG SHEATH (STRYKER); EXCELSIOR SL 10 MICROCATHETER (STRYKER)
• Patient Sex: Unknown