MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO-14 STRAIGHT 300-35CM; WIRE, GUIDE, CATHETER

Catalog Number	M00313310
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that when delivering the subject guidewire, to better adjust its position, the subject guidewire was rotated proximal end outside patient's body.When the subject guidewire reached the position, the distal of the subject guidewire was not rotating with the proximal movement.Therefore, the subject guidewire was withdrawn and found the distal of the subject guidewire was fractured.10cm of the fractured tip was left inside the patient's body and the snare device was used to remove the fractured.The subject guidewire was replaced with a new guidewire 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.Visual inspection was performed as the subject guidewire was confirmed to have been fractured with 2 distal sections detached (12.5cm & 2cm).There was also kinking/deformation noted to the distal tip.There were multiple fractures to the nitinol tubing noted.The functional test was not required as the subject guidewire was fractured.The reported complaint was confirmed based on analysis.The subject 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.It was reported that when the operator tried to withdraw the subject guidewire, the distal end of the subject guidewire was fractured and 10cm of the tip was left inside the patient's body.Additional information provided by the customer indicated that the subject device was prepared for use as per the dfu.There was no damage noted to the packaging prior to opening the packaging.The subject 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.The operator used snare device to take the fractured subject guidewire and additional intervention was required to prevent permanent impairment.During analysis, the subject guidewire was confirmed to be fractured with 2 distal sections detached.Multiple fractures to the nitinol tubing were noted.There was also deformation noted to the distal tip.The reported difficulty to transfer torque to the distal tip can be confirmed as the distal tip was fractured.It is probable that there may have been procedural and/or anatomical factors present during the procedure which may have caused the nitinol tubing to separate from the guidewire core wire, therefore an assignable cause of procedural factors will be assigned to the reported 'guidewire distal tip broken/fractured during use' and 'guidewire torque problem' as well as analyzed 'guidewire distal tip broken/fractured during use' and also as analyzed 'guidewire distal end/tip kinked/bent', 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
It was reported that when delivering the subject guidewire, to better adjust its position, the subject guidewire was rotated proximal end outside patient's body.When the subject guidewire reached the position, the distal of the subject guidewire was not rotating with the proximal movement.Therefore, the subject guidewire was withdrawn and found the distal of the subject guidewire was fractured.10cm of the fractured tip was left inside the patient's body and the snare device was used to remove the fractured.The subject guidewire was replaced with a new guidewire and continued the procedure without clinical consequences to the patient.

• Brand Name: SYNCHRO-14 STRAIGHT 300-35CM
• 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: 20772386
• Report Number: 3012931345-2024-00205
• Device Sequence Number: 4399919
• Product Code: DQX
• UDI-Device Identifier: 07613252186946
• UDI-Public: (01)07613252186946(17)251024(10)0000576543
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K002907
• 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): 02/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/24/2025
• Device Catalogue Number: M00313310
• Device Lot Number: 0000576543
• 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: 11/07/2024
• Supplement Date Received by Manufacturer: 01/24/2025
• Initial Report FDA Received Date: 11/25/2024
• Supplement Report FDA Received Date: 02/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Patient Race: Asian