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	Foreign Body In Patient (2687)
Date of Event	08/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the subject guidewire was used with other devices in right va accute occlusion case.When passing the subject guidewire through the lesion, the operator checked under dsa (digital subtraction angiography) showed the tip 15cm of the subject guidewire was fractured.The operator pulled the subject guidewire and microcatheter out and replaced the subject guidewire with another one.The balloon catheter was used to dilate the lesion and completed the procedure successfully.The fractured tip of the subject guidewire was left inside the patient's body.There were no adverse consequences related to an un retrieved device fragment.
Event or Problem Description
It was reported that the subject guidewire was used with other devices in right va accute occlusion case.When passing the subject guidewire through the lesion, the operator checked under dsa (digital subtraction angiography) showed the tip 15cm of the subject guidewire was fractured.The operator pulled the subject guidewire and microcatheter out and replaced the subject guidewire with another one.The balloon catheter was used to dilate the lesion and completed the procedure successfully.The fractured tip of the subject guidewire was left inside the patient's body.There were no adverse consequences related to an un retrieved device fragment.
Additional Manufacturer Narrative
D4 gtin: corrected to (b)(4).D4 expiration date - added.H4 manufacturing date ¿ added.There are controls in the manufacturing process to ensure the product met specifications upon release.The subject guidewire device is not available; therefore, a visual inspection as well as a functional evaluation could not be performed.The reported events could not be confirmed and it cannot be confirmed that the device met specification, as the device was not returned.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 placed 6f guiding to v1 section and then subject guidewire device and microcatheter to pass the lesion.However, when passing through the lesion the operator checked under dsa (digital subtraction angiography) to find tip 15cm of the subject guidewire device got fractured.The operator pulled the subject guidewire device and microcatheter out and replaced the subject guidewire device with another one and used gateway balloon to dilate the lesion to finish the procedure successfully.The fractured tip of subject guidewire was left inside patient's vessel.Additional information received, indicates that continuous flush was set up and maintained throughout the clinical procedure and the patient's anatomy was severely tortuous.There was some difficulty rotating the guidewire using the torque device.The subject guidewire device was not returned for analysis.Based on a review of all available information it is possible that the patients severely tortuous anatomy may have caused some difficulties in navigating the subject guidewire device to its intended location causing the subject guidewire device to fracture.An assignable cause of procedural factors will be assigned to this complaint, 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: 20190604
• Report Number: 3012931345-2024-00170
• Device Sequence Number: 7002764
• Product Code: DQX
• UDI-Device Identifier: 04546540688781
• UDI-Public: (01)04546540688781(17)261204(10)0000594694
• 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): 12/12/2024

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 Catalogue Number: M00326510
• Device Lot Number: 0000594694
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/02/2024
• Supplement Date Received by Manufacturer: 11/21/2024
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/06/2023
• 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 GUIDING CATHETER (STRYKER); GATEWAY BALLOON CATHETER (STRYKER); XT-27 MICROCATHETER (STRYKER)
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 55 KG
• Patient Race: Asian