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	12/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during intracranial artery stenosis (icas) procedure the operator delivered the subject guidewire to pass the lesion.When the operator tried to deliver the subject guidewire to go into distal of vessel, the distal of the subject guidewire didn't react as the proximal did.So, the operator found the subject guidewire fractured.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
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 there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection the guidewire was returned in two fragments (190cm proximal fragment and 10cm distal fragment).The proximal fragment was inspected and was noted to be broken along the nitinol tubing with the core/platinum wire exposed.The distal fragment was inspected, and the nitinol tubing was seen to be broken and core wire and platinum wire exposed.The core wire distal end was observed through the distal tip dome.Functional 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 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 there was no damage noted to the packaging prior to opening the packaging, there was no anomalies noted to the device during initial inspection and preparation, the device was prepared for use as per the directions for use, continuous flush was set up and maintained throughout the clinical procedure.The patient¿s anatomy was moderately tortuous.During analysis the guidewire was returned in two fragments 190cm and 10cm.An assignable cause of procedural factors will be assigned to the reported and analyzed event ¿ 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 intracranial artery stenosis (icas) procedure the operator delivered the subject guidewire to pass the lesion.When the operator tried to deliver the subject guidewire to go into distal of vessel, the distal of the subject guidewire didn't react as the proximal did.So, the operator found the subject guidewire fractured.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 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: 18476633
• Report Number: 3012931345-2024-00005
• Device Sequence Number: 20434932
• Product Code: DQX
• UDI-Device Identifier: 04546540688729
• UDI-Public: 04546540688729
• 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): 02/06/2024

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: 02/11/2026
• Device Catalogue Number: M00326010
• Device Lot Number: 0000223826
• 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: 12/21/2023
• Supplement Date Received by Manufacturer: 01/21/2024
• Initial Report FDA Received Date: 01/09/2024
• Supplement Report FDA Received Date: 02/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2023
• 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: REBAR CATHETER (NON-STRYKER).
• Patient Age: 41 YR
• Patient Sex: Male
• Patient Race: Asian