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	01/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during stenosis case, when the physician used the subject guidewire to super select the vessel, under dsa (digital subtraction angiography) the physician found distal of the subject guidewire fractured at c3 segment.The physician then used middle catheter and balloon as a medical intervention to take the fractured subject guidewire out.It took the physician about 2 hours to take the fractured subject guidewire out.The current condition of the patient is stable.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
H3 other text : the device is not available to the manufacturer.
Additional Manufacturer Narrative
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.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 distal 11cm was noted to be broken fractured with the core wire exposed.There was some shaping noted to the distal tip of the guidewire.The distal niti fracture was imaged with exposed core wire (15mm).The core wire fracture was imaged with necking noted to the fracture point.The proximal niti fracture point was imaged.A functional inspection was not performed as the guidewire was 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.It was reported that, the operator used guidewire to super select the vessel and under dsa (digital subtraction angiography) the operator found distal of the guidewire fractured at c3 segment.The operator then used middle catheter and balloon to help to take the fractured guidewire out.Additional information provided by the customer indicated that continuous flush was set up and maintained throughout the clinical procedure and the patients anatomy was not tortuous.The device was returned for analysis, the guidewire niti tubing was noted to be fractured towards the distal tip with the core wire fractured and exposed.There was necking noted to the core wire fracture point, which is indicative of tension forces being applied to the guidewire.It is probable that the guidewire fractured as a result of forces applied to the guidewire during use.An assignable cause of procedural factors will be assigned to the reported and analyzed 'guidewire distal tip 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.
Event or Problem Description
It was reported that during stenosis case, when the physician used the subject guidewire to super select the vessel, under dsa (digital subtraction angiography) the physician found distal of the subject guidewire fractured at c3 segment.The physician then used middle catheter and balloon as a medical intervention to take the fractured subject guidewire out.It took the physician about 2 hours to take the fractured subject guidewire out.The current condition of the patient is stable.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: 18576227
• Report Number: 3012931345-2024-00016
• Device Sequence Number: 21122972
• 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): 02/23/2024

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: 12/02/2025
• Device Catalogue Number: M00326310
• Device Lot Number: 0000204579
• 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: 01/11/2024
• Supplement Date Received by Manufacturer: 02/22/2024
• Initial Report FDA Received Date: 01/24/2024
• Supplement Report FDA Received Date: 02/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2022
• 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: GATEWAY BALLOON (STRYKER); MIDDLE CATHETER (UNKNOWN); STENT (UNKNOWN)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Patient Race: Asian