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

Catalog Number	M00326310
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 other text : the device is not available to the manufacturer.
Event or Problem Description
It was reported that during aneurysm embolization case the proximal of the parent vessel was very tortuous.The operator used the guidewire and the microcatheter to go into the parent vessel but they could not be delivered.The operator withdrew the guidewire and found that it was kinked.Thus, the operator replaced it with the subject guidewire.During delivery of the subject guidewire the operator found its tip was abnormal.On withdrawal, tip of the subject guidewire was fractured inside the microcatheter.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
This is 2 of 2 reports (2nd mdr).H4 manufacturing date ¿ added.H3 device evaluated by mfg ¿updated.H3 summary attached - updated.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 returned broken in two fragments (288cm and 13.3cm).The guidewire was seen to have a slight kink 231cm from the proximal end.The proximal fragment was inspected, and the nitinol tubing was broken/fractured.The distal fragment was inspected, and the nitinol tubing was broken with the core wire exposed.The core wire was seen through the distal tip dome.Functional inspection was not performed as the guidewire was broken/fractured.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 was confirmed based on analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.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 and was prepared for use as per the dfu, continuous flush was set up and maintained throughout the clinical procedure, the proximal of the parent vessel was very tortuous, microcatheter was used with the subject guidewire, the guidewire tip was shaped 30 degrees, the operator felt the torque control force reduced at the tip during delivery after several tries, and it was noted that it was hard to deliver the product smoothly in the patient's vessel.Based on the analysis and information provided, it is probable that the guidewire experienced high tension and/or torsion forces during delivery through the tortuous portion of the parent vessel, causing the wire to fracture.An assignable cause of procedural factors will be assigned to the reported and analyzed event 'guidewire distal tip broken/fractured during use', the reported event 'guidewire torque problem', and the analyzed event 'guidewire kinked/bent' since these issues are associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu but performance was limited due to procedural and/or anatomical factors during use.
Event or Problem Description
It was reported that during aneurysm embolization case the proximal of the parent vessel was very tortuous.The operator used the guidewire and the microcatheter to go into the parent vessel but they could not be delivered.The operator withdrew the guidewire and found that it was kinked.Thus, the operator replaced it with the subject guidewire.During delivery of the subject guidewire the operator found its tip was abnormal.On withdrawal, tip of the subject guidewire was fractured inside the microcatheter.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: SYNCHRO2-14 SOFT 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: 18098461
• Report Number: 3012931345-2023-00242
• Device Sequence Number: 12670933
• Product Code: DQX
• UDI-Device Identifier: 04546540688743
• UDI-Public: 04546540688743
• 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): 01/05/2024

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 Expiration Date: 06/25/2025
• Device Catalogue Number: M00326310
• Device Lot Number: 0000147987
• 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: 10/16/2023
• Supplement Date Received by Manufacturer: 12/12/2023
• Initial Report FDA Received Date: 11/09/2023
• Supplement Report FDA Received Date: 01/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2022
• 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: EXCELSIOR SL-10 MICROCATHETER (STRYKER).
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 50 KG
• Patient Race: Asian