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

Model Number	SSUP215PRE
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure, the subject guidewire unraveled after being pulled from a patient.No further information is available.
Event or Problem Description
It was reported that during a procedure, the subject guidewire unraveled after being pulled from a patient.No further information is available.
Additional Manufacturer Narrative
There are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, functional testing as well as visual testing cannot be performed.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 could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.It was reported that the subject guidewire unraveled after being pulled from the patient.No additional information was received on the case.While there are a number of potential causes for the reported issue, because review of available information failed to identify a definitive cause and the device was not returned for analysis, an assignable cause of undeterminable was assigned to the as reported ¿guidewire broken/fractured during use¿.H3 other text : the device is not available to the manufacturer.
Additional Manufacturer Narrative
H3 device evaluated by mfg ¿ updated.H3 summary attached - updated.H6 method code grid (1) - corrected.H6 results code grid (1) - corrected.H6 conclusion code grid (1) - corrected.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 inspection, the guidewire was noted to be kinked/bent at 112cm from the proximal end.The guidewire was found to be broken/fractured roughly 209cm from the proximal end.The proximal fragment was inspected, and the nitinol tubing was broken/fractured with the core wire exposed and broken.The distal end of the guidewire was not returned.Functional inspection was 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 the subject guidewire unraveled after being pulled from the patient.No additional information was received on the case.During the visual inspection, the guidewire was noted to be kinked/bent at 112cm from the proximal end and was found to be broken/fractured roughly 209cm from the proximal end, confirming the reported event.The distal end of the fractured guidewire was not returned.On the proximal fragment, the nitinol tubing was noted to be broken/fractured with the core wire and platinum wire exposed.The core wire and platinum wire were also broken/fractured.Based on the analysis, it is probable that the guidewire experienced high tension and/or torsion forces during manipulation of the wire, and this caused the wire to kink and fracture.An assignable cause of procedural factors will be assigned to the as reported and as analyzed 'guidewire broken/fractured during use' as well as the as analyzed 'guidewire kinked/bent' since these issues are associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu but performance was limited due to procedural and/or anatomical factors during use.
Event or Problem Description
It was reported that during a procedure, the subject guidewire unraveled after being pulled from a patient.No further information is available.

• Brand Name: SYNCHRO SELECT-14 SUPPORT 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: 16959552
• Report Number: 3012931345-2023-00090
• Device Sequence Number: 17490976
• Product Code: MOF
• UDI-Device Identifier: 07613327508635
• UDI-Public: 07613327508635
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• 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): 08/23/2023

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: Health Professional
• Device Expiration Date: 12/06/2025
• Device Model Number: SSUP215PRE
• Device Catalogue Number: SSUP215PRE
• Device Lot Number: 0000206200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/25/2023
• Supplement Date Received by Manufacturer: 05/31/2023; 07/31/2023
• Initial Report FDA Received Date: 05/19/2023
• Supplement Report FDA Received Date: 06/22/2023; 08/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2022
• 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
• Patient Sex: Unknown