MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO2-14 SOFT STRAIGHT 200CM; WIRE, GUIDE, CATHETER

Catalog Number	M00326010
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
During an aneurysm embolization procedure, the operator placed a long sheath to left ica (internal carotid artery) petrous segment and then placed dac device (distal access catheter ) with the subject guidewire to place the dac device to cavernous segment.The subject guidewire was withdrawn and delivered the microcatheter tip to go into aneurysm and then filled with coil.Then used the second microcatheter to go to left mca (middle cerebral artery) distal and deployed a flow diverter stent.After deployment, the operator used microcatheter to work with a subject guidewire to message the stent inside of it, and then dsa (digital subtraction angiography) showed the subject guidewire was fractured.The retriever device was used to remove the fractured guidewire and finished the procedure.No other information was provided.
Event or Problem Description
During an aneurysm embolization procedure, the operator placed a long sheath to left ica (internal carotid artery) petrous segment and then placed dac device (distal access catheter ) with the subject guidewire to place the dac device to cavernous segment.The subject guidewire was withdrawn and delivered the microcatheter tip to go into aneurysm and then filled with coil.Then used the second microcatheter to go to left mca (middle cerebral artery) distal and deployed a flow diverter stent.After deployment, the operator used microcatheter to work with a subject guidewire to message the stent inside of it, and then dsa (digital subtraction angiography) showed the subject guidewire was fractured.The retriever device was used to remove the fractured guidewire and finished the procedure.No other information was provided.
Additional Manufacturer Narrative
D4 expiration date added.D4 gtin updated h4 manufacturing date added.There are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, visual and functional testing as well as physical analysis cannot be performed.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 could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.It was reported that after deployment the operator used microcatheter to work with a guidewire to message the stent inside of it, and then dsa (digital subtraction angiography) showed the guidewire fractured.The operator then delivered a retriever to try to catch the guidewire out and finished the procedure.Additional information provided states 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 set up and maintained throughout the clinical procedure and the patients anatomy was moderately tortuous.The guidewire tip was shaped and there was no friction experienced during the procedure.It is probable that the guidewire was damaged during the attempt to message the flow diverter stent with the microcatheter and guidewire.The patients anatomy may also have contributed to the guidewire damage.An assignable cause of procedural factors will be assigned to the reported 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.

• Brand Name: SYNCHRO2-14 SOFT STRAIGHT 200CM
• 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: 19833548
• Report Number: 3012931345-2024-00139
• Device Sequence Number: 18170562
• Product Code: DQX
• UDI-Device Identifier: 04546540688729
• UDI-Public: (01)04546540688729(17)260731(10)0000541162
• 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): 10/17/2024

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: 07/31/2026
• Device Catalogue Number: M00326010
• Device Lot Number: 0000541162
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/05/2024
• Supplement Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/02/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 6F LONG SHEATH (STRYKER).; COIL (UNKNOWN MANUFACTURER).; DAC (STRYKER).; FLOW DIVERTER STENT (STRYKER).; MICROCATHETER (UNKNOWN MANUFACTURER).; STENT RETRIEVER (STRYKER).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Unknown
• Patient Race: Asian