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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during one left m1 stenosis case, the operator flushed and delivered the subject guidewire to c1 segment, and the delivery was smooth.However, the patient's vessel was quite tortuous so when used the subject guidewire to reach the lesion, the operator felt tip of the subject guidewire was not rotating inside patient's vessel.The subject guidewire was withdrawn and found it was fractured.Replaced it with another guidewire to continue the procedure.There were no clinical consequences reported to the patient due to this event.
Event or Problem Description
It was reported that during one left m1 stenosis case, the operator flushed and delivered the subject guidewire to c1 segment, and the delivery was smooth.However, the patient's vessel was quite tortuous so when used the subject guidewire to reach the lesion, the operator felt tip of the subject guidewire was not rotating inside patient's vessel.The subject guidewire was withdrawn and found it was fractured.Replaced it with another guidewire to continue the procedure.There were no clinical consequences reported to the patient due to this event.
Additional Manufacturer Narrative
D4 expiration date: added.D9 product available to stryker / returned to manufacturer on: updated.H3 device evaluated by mfg: updated.H4 manufacturing date: added.There are controls in the manufacturing process to ensure the product met specifications upon release.Visual inspection of the returned subject guidewire device revealed that the subject guidewire was seen to be kinked/bent and fractured at 165 cm from the proximal end.The functional testing could not be performed due to the condition of the returned device.The reported ¿guidewire distal tip broken/fractured during use¿ can be confirmed based on the analysis, however it was not the distal tip, it was confirmed to be 34cm from the distal tip.The reported difficulty engaging target vessel could not be duplicated as the event is procedure/patient related.The device failed to meet specification when returned for analysis.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 the patient's vessel was quite tortuous so when used the subject guidewire to reach the lesion, the operator felt the tip of the subject guidewire was not rotating inside patient's vessel.The subject guidewire was removed from the patient and found it was fractured.Additional information provided by the customer indicated that continuous flush was set up and maintained throughout the clinical procedure, and the patients anatomy was severely tortuous.Analysis of the returned subject guidewire device found the subject guidewire was fractured at 34cm from the distal end, confirming the reported event.There was also some kinking noted to the subject guidewire.The damage to the returned subject guidewire device indicates that an excessive force may have been applied to the wire most likely due to navigation and torqueing through the severely tortuous anatomy.An assignable cause of procedural factors will be assigned to the reported ¿guidewire distal tip broken/fractured during use¿ and ¿device difficulty engaging target vessel¿ as to the analysed ¿ 'guidewire broken/fractured during use¿ and ¿guidewire kinked/bent¿, 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: 19377351
• Report Number: 3012931345-2024-00091
• Device Sequence Number: 15330909
• Product Code: DQX
• UDI-Device Identifier: 07613252186946
• UDI-Public: 07613252186946
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K032146
• 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): 07/22/2024

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: 07/10/2024
• Device Catalogue Number: M00313310
• Device Lot Number: 0000153160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2024
• Supplement Date Received by Manufacturer: 07/04/2024
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2022
• 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: CATALYST 5 (STRYKER).; GATEWAY CATHETER (STRYKER).; SYNCHRO EZ (STRYKER).; XT-27 MICROCATHETER (STRYKER).
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Race: Asian