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

Catalog Number	M00326510
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a procedure to address middle cerebral artery (mca) m2 stenosis, a long sheath was used in conjunction with a middle catheter to establish access.Used the subject guidewire to work with a non-stryker microcatheter to pass the stenosis.The operator pushed the proximal end of the subject guidewire and checked under digital subtraction angiography (dsa) to confirm that the tip had not moved.While attempting to withdraw the subject guidewire, the distal end was still not moving.The operator locked the microcatheter and the proximal end of the subject guidewire, withdrawing the system together into the middle catheter before fully removing it.When checked, it was discovered that the tip of the subject guidewire had fractured.The fractured tip was left in the distal m2 stenosis.A retriever device was used as a medical intervention to remove the fractured tip, and the procedure was successfully completed without any fragments left inside the patient.No clinical consequences were reported as a result of this event.
Additional Manufacturer Narrative
D4 expiration date - added.D9 product available to stryker ¿ updated.D9 returned to manufacturer on ¿updated.There are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the guidewire was noted to be kinked/bent.The guidewire was noted to be broken/fractured approx.90cm from the proximal end and at the tip.The core wire distal end was observed through the distal tip dome.The guidewire ptfe (ptfe) polytetrafluoroethylene was noted to be damaged 155 cm from the proximal end.A function 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 fracture was confirmed.The device failed to meet specification when returned for analysis.It was reported that used a guidewire to work with anon-stryker microcatheter to pass the stenosis and then the operator pushed the proximal of guidewire and checked under dsa (digital subtraction angiography) to see that tip of it was not moved.Tried to withdraw the guidewire and distal was still not moving.Finally locked the microcatheter and the proximal of guidewire and withdrew the system together to middle catheter and pulled out.Checked on the table to see the tip of guidewire got fractured.Tip of the guidewire left inside the m2 stenosis distal and used a 4-40 retriever to take the fractured tip out and continued the procedure.Additional information provided by the customer indicated that 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 moderately tortuous.The wire was torqued to overcome the resistance.Analysis of the returned device found the guidewire had been fractured and kinked, there was some damage noted to the proximal ptfe coating.It is probable that the guidewire was fractured as it was torqued to overcome resistance.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 distal tip broken/fractured during use', and to the analyzed 'guidewire 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.The damage noted to the guidewire ptfe coating is consistent with interaction with the torque device, which may have been under tightened.Therefore an assignable cause of handling damage will be assigned to the analyzed 'guidewire ptfe coating peeling.'.
Event or Problem Description
It was reported that during a procedure to address middle cerebral artery (mca) m2 stenosis, a long sheath was used in conjunction with a middle catheter to establish access.Used the subject guidewire to work with a non-stryker microcatheter to pass the stenosis.The operator pushed the proximal end of the subject guidewire and checked under digital subtraction angiography (dsa) to confirm that the tip had not moved.While attempting to withdraw the subject guidewire, the distal end was still not moving.The operator locked the microcatheter and the proximal end of the subject guidewire, withdrawing the system together into the middle catheter before fully removing it.When checked, it was discovered that the tip of the subject guidewire had fractured.The fractured tip was left in the distal m2 stenosis.A retriever device was used as a medical intervention to remove the fractured tip, and the procedure was successfully completed without any fragments left inside the patient.No clinical consequences were reported as a result of this event.

• 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: 21022665
• Report Number: 3012931345-2024-00222
• Device Sequence Number: 9181303
• Product Code: DQX
• UDI-Device Identifier: 04546540688781
• UDI-Public: (01)04546540688781(17)270312(10)0000633358
• 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): 03/12/2025

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 Catalogue Number: M00326510
• Device Lot Number: 0000633358
• 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: 12/04/2024
• Supplement Date Received by Manufacturer: 02/26/2025
• Initial Report FDA Received Date: 12/26/2024
• Supplement Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2024
• 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: 6F LONG SHEATH (UNKNOWN); MIDDLE CATHETER (UNKNOWN); RETRIEVER (UNKNOWN); RUIKANGTONG MICROCATHETER (NON-STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Race: Asian