MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO-14 STRAIGHT 200-35CM; WIRE, GUIDE, CATHETER

Catalog Number	M00313010
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a thrombus retrieval surgery, the physician utilized the subject guidewire to select the embolized blood vessel.During the selection process, the physician torqued the subject guidewire.However, during the torque manipulation, the middle section of the subject guidewire broke when positioned at the distal segment of the internal carotid artery (ica), although the core wire remained partially connected.The physician carefully withdrew the subject guidewire slowly towards the proximal end until it was fully withdrawn into the guiding catheter.Subsequently, when withdrawing the guiding catheter, the subject guidewire completely fractured.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Event or Problem Description
It was reported that during a thrombus retrieval surgery, the physician utilized the subject guidewire to select the embolized blood vessel.During the selection process, the physician torqued the subject guidewire.However, during the torque manipulation, the middle section of the subject guidewire broke when positioned at the distal segment of the internal carotid artery (ica), although the core wire remained partially connected.The physician carefully withdrew the subject guidewire slowly towards the proximal end until it was fully withdrawn into the guiding catheter.Subsequently, when withdrawing the guiding catheter, the subject guidewire completely fractured.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
H3 device evaluated by mfg ¿updated d9 product available to stryker ¿ updated d9 returned to manufacturer on ¿updated due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the guidewire proximal end was noted to be kinked/bent.The guidewire was noted to be broken/fractured approx.182cm from the proximal end.The distal section of the wire was not returned.A 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 'guidewire distal tip broken/fractured during use' was confirmed.The device failed to meet specification when returned for analysis.It was reported that during the selection process, the physician torqued the guidewire.However, during the torque manipulation, the middle section of the guidewire broke, although the core wire remained partially connected.The physician carefully withdrew the guidewire slowly towards the proximal end until it was fully withdrawn into the guiding catheter.Subsequently, when withdrawing the guiding catheter, the guidewire completely fractured.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 moderately tortuous.The device was returned and it was conformed that the guidewire had been fractured, there was also kinking noted to the proximal end of the guidewire.It is probable that the guidewire was fractured as it was torqued, possibly due to anatomical and /or procedural factors.As per the synchro ifu: " never advance, auger, withdraw, or torque a guidewire which meets resistance.Resistance may be felt and/or observed under fluoroscopy by noting any buckling or prolapse of the guidewire tip.Excessive force against resistance may result in damage to the guidewire, such as separation of the guidewire tip, damage to the interventional device, and/or vessel perforation.Determine the cause of the resistance under fluoroscopy and take any necessary remedial action".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.The kink to the proximal end of the guidewire is likely due to handling of the device during the clinical procedure, therefore an assignable cause of handling damage will be assigned to the analyzed 'guidewire kinked/bent.'.

• Brand Name: SYNCHRO-14 STRAIGHT 200-35CM
• 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: 21590431
• Report Number: 3012931345-2025-00059
• Device Sequence Number: 8350700
• Product Code: DQX
• UDI-Device Identifier: 07613252186922
• UDI-Public: (01)07613252186922(17)260508(10)0000661138
• 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): 05/30/2025

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: 05/08/2026
• Device Catalogue Number: M00313010
• Device Lot Number: 0000661138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/20/2025
• Supplement Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2024
• 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: GUIDING CATHETER (UNKNOWN).; PRO18 MICROCATHETER (NON-STRYKER).
• Patient Sex: Unknown