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

Model Number	M00326510
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a neurovascular procedure the subject guidewire could not pass the ica (internal carotid artery) siphon section to distal occlusion.The subject guidewire was retrieved and it was found that fractured at tip with core wire connected.70 percentage stenosis and calcification at the lesion was reported.The subject guidewire was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
This is 2 of 2 reports (2nd mdr) h3 other text : the device is not available to the manufacturer.
Event or Problem Description
It was reported that during a neurovascular procedure the subject guidewire could not pass the ica (internal carotid artery) siphon section to distal occlusion.The subject guidewire was retrieved and it was found that fractured at tip with core wire connected.70 percentage stenosis and calcification at the lesion was reported.The subject guidewire was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
There are controls in the manufacturing process to ensure the product met specifications upon release.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.Analysis of the returned device found the guidewire niti tubing was fractured with stretching noted to the platinum coil.The damage noted to the returned device is indicative of excessive forces being applied to the guidewire, most likely during the attempt to retract the device from the patients anatomy.Additional information provided by the customer indicated the device was prepared for use as per the directions for use, 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.There was no resistance encountered during the usage of the device that could have contributed to the issue, there was 70% stenosis and calcification at the lesion.An assignable cause of procedural factors will be assigned to the as reported ¿guidewire distal tip broken/fractured during use¿ and to the analyzed 'guidewire distal tip stretched' and '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.

• Brand Name: SYNCHRO2-14 STANDARD 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: 17264476
• Report Number: 3012931345-2023-00153
• Device Sequence Number: 15424430
• Product Code: DQX
• UDI-Device Identifier: 04546540688781
• UDI-Public: 04546540688781
• 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): 09/12/2023

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: 12/17/2025
• Device Model Number: M00326510
• Device Catalogue Number: M00326510
• Device Lot Number: 0000209222
• 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: 06/13/2023
• Supplement Date Received by Manufacturer: 08/15/2023
• Initial Report FDA Received Date: 07/06/2023
• Supplement Report FDA Received Date: 09/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2022
• 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 Age: 45 YR
• Patient Sex: Male
• Patient Weight: 50 KG
• Patient Race: Asian