MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO-14 STRAIGHT 300-35CM; WIRE, GUIDE, CATHETER

Catalog Number	M00313310
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a right internal carotid artery (ica) occlusion case, when super selecting subject guidewire to a2-a3 segment of patient¿s anatomy, the distal tip of the subject guidewire got fractured.Operator attempted to use a balloon as medical intervention to work with catheter to retrieve the fractured part of subject guidewire out but was unsuccessful.The procedure was not completed and surgical delay of 3 hour was observed.The fractured part of subject guidewire was left inside the patient's vessel.Patient was discharged from the hospital and the current status is not available.
Event or Problem Description
It was reported that during a right internal carotid artery (ica) occlusion case, when super selecting subject guidewire to a2-a3 segment of patient¿s anatomy, the distal tip of the subject guidewire got fractured.Operator attempted to use a balloon as medical intervention to work with catheter to retrieve the fractured part of subject guidewire out but was unsuccessful.The procedure was not completed and surgical delay of 3 hour was observed.The fractured part of subject guidewire was left inside the patient's vessel.Patient was discharged from the hospital and the current status is not available.
Additional Manufacturer Narrative
G4 pma/510(k - corrected.D4 gtin - corrected.H4 manufacturing date ¿ added.D4 expiration date - added.There are controls in the manufacturing process to ensure the product met specifications upon release.The subject guidewire was not returned for analysis; therefore, physical as well as a functional testing could not be performed.The reported event is covered in the device direction 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 event cannot be confirmed, and it cannot be confirmed that the device met specification, as the device was not returned.Additional information provided by the customer states that the patients anatomy was moderately tortuous.The subject guidewire was not returned for analysis.It was reported that the subject guidewire got fractured after several manipulations, it is likely that these manipulations coupled with the anatomical factors present during the clinical procedure let to the subject guidewire becoming fractured.An assignable cause of procedural factors will be assigned to this complaint codes guidewire distal tip broken/fractured during use and un-retrieved device fragments, 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: SYNCHRO-14 STRAIGHT 300-35CM
• 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: 19918001
• Report Number: 3012931345-2024-00140
• Device Sequence Number: 18166459
• Product Code: DQX
• UDI-Device Identifier: 07613252186946
• UDI-Public: (01)07613252186946(17)250716(10)0000484785
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K002907
• 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): 10/28/2024

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: 07/16/2025
• Device Catalogue Number: M00313310
• Device Lot Number: 0000484785
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/16/2024
• Supplement Date Received by Manufacturer: 10/04/2024
• Initial Report FDA Received Date: 08/06/2024
• Supplement Report FDA Received Date: 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/18/2023
• 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: AXS CATALYST 6 CATHETER (STRYKER).; BALLOON (UNKNOWN).
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Race: Asian