MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO2-14 SUPPORT STRAIGHT 215CM; WIRE, GUIDE, CATHETER

Catalog Number	S2SPS14215
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was during the procedure, the subject guidewire was torn approximately in the distal to middle third during an intervention in the microcatheter.The procedure was completed as no clinical consequence to the patient reported as a result of this event.No other information was provided.
Event or Problem Description
It was during the procedure, the subject guidewire was torn approximately in the distal to middle third during an intervention in the microcatheter.The procedure was completed as no clinical consequence to the patient reported as a result of this 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.Visual inspection was performed as the returned subject guidewire was noted to be broken/fractured approx.210 cm from the proximal end and the subject guidewire ptfe (polytetrafluoroethylene) was seen to be peeling approx., 50 cm from the proximal end.A functional inspection was not required due to the damage to the subject guidewire.The reported guidewire broken/fractured during use was confirmed during analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.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 indicated that there was no damage noted to the packaging prior to opening the packaging, there was no anomalies noted to the device during initial inspection and preparation, the device was prepared for use as per the directions for use, continuous flush was set up and maintained throughout the clinical procedure.The patient¿s anatomy was severely tortuosity.During analysis the guidewire was noted to be broken/fractured approx.210 cm from the proximal end.The ptfe was seen to be peeling approximately 50 cm from the proximal.It is possible the patients anatomy and the torque device may have been pulled causing linear damage.An assignable cause of procedural factors will be assigned to the reported and analyzed ¿guidewire 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.An assignable cause of 'handling damage' will be assigned to the analyzed 'guidewire ptfe coating peeling' as the defect appears to be associated with handling of the product or portion of the product during preparation.

• Brand Name: SYNCHRO2-14 SUPPORT STRAIGHT 215CM
• Common Device Name: WIRE, GUIDE, CATHETER
• 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: 19366799
• Report Number: 3012931345-2024-00088
• Device Sequence Number: 17090210
• Product Code: DQX
• UDI-Device Identifier: 07613327459630
• UDI-Public: 07613327459630
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K053268
• 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): 07/19/2024

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: 01/30/2026
• Device Catalogue Number: S2SPS14215
• Device Lot Number: 0000220770
• 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: 05/14/2024
• Supplement Date Received by Manufacturer: 07/09/2024
• Initial Report FDA Received Date: 05/21/2024
• Supplement Report FDA Received Date: 07/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2023
• 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
• Patient Sex: Unknown