MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO2-14 SUPPORT STRAIGHT 300CM; WIRE, GUIDE, CATHETER

Catalog Number	S2SPS14300
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the chronic intracranial occlusion procedure, during manipulation within the microcatheter, the guidewire fractured.The physician was able to remove the entire fractured guidewire as it still remained in the microcatheter.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
H3 other text : the device is not available to the manufacturer.
Event or Problem Description
It was reported that during the chronic intracranial occlusion procedure, during manipulation within the microcatheter, the guidewire fractured.The physician was able to remove the entire fractured guidewire as it still remained in the microcatheter.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
There are controls in the manufacturing process to ensure the product met specifications upon release.The device was returned.The reported lot number was not confirmed as the packaging was not returned with the device.During visual inspection, the guidewire ptfe (polytetrafluoroethylene) coating was seen to be peeling at 135cm from the proximal end.The guidewire was returned in two fragments.(293cm proximal fragment and 7cm distal fragment).The proximal fragment was inspected, and the nitinol tubing was broken/fractured with the core wire exposed and broken.The distal fragment was inspected, and the nitinol tubing was seen to be broken with the platinum wire exposed at 6.4cm.The distal fragment was inspected, and the nitinol tubing was broken/fractured with the core wire exposed and broken.The core wire distal end was observed through the distal tip dome.Functional testing was not completed due to device condition.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.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 not tortuous.The guidewire was returned and it was confirmed that the distal section of the guidewire had been fractured and the guidewire ptfe coating was peeling.Confirming the reported event.An assignable cause of procedural factors will be assigned to the reported and analysed event of 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 as analysed event of 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 300CM
• 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: 17818697
• Report Number: 3012931345-2023-00213
• Device Sequence Number: 14039137
• Product Code: DQX
• UDI-Device Identifier: 07613327459647
• UDI-Public: 07613327459647
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 11/02/2023

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: 06/05/2025
• Device Catalogue Number: S2SPS14300
• Device Lot Number: 0000140967
• 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: 09/08/2023
• Supplement Date Received by Manufacturer: 10/19/2023
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 11/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2022
• 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: REBAR 18 MICROCATHETER (MEDTRONIC); REBAR 18 MICROCATHETER (MEDTRONIC)
• Patient Sex: Unknown
• Patient Race: Asian