MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO-14 STRAIGHT 200-45CM; WIRE, GUIDE, CATHETER

Catalog Number	M00313020
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the subject guidewire tip broke during the procedure.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Event or Problem Description
It was reported that the subject guidewire tip broke during the procedure.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added h3 device evaluated by mfg ¿updated d4 expiration date - added d9 product available to stryker ¿ updated d9 returned to manufacturer on ¿updated d4 gtin - corrected there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection the guidewire and guidewire distal tip were noted to be kinked/bent.The guidewire was noted to be broken/fractured approx.183 cm from the proximal end.The guidewire polytetrafluoroethylene (ptfe) was seen to be peeling approx., 48 cm from the proximal end.The core wire distal end was observed through the distal tip dome.Functional inspection was not required as the reported event was confirmed during visual inspection.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 event was confirmed based on the damage noted to the returned device.The device failed to meet specification when returned for analysis.The event reported "synchro wire broke during a case.Body had a synchro break about 5¿ from the tip.Patient was not harmed, and dr.Taylor got the wire out without too much trouble.He was not torquing too hard or doing anything weird, anatomy was not too tortuous".Analysis of the returned device found the guidewire and guidewire distal tip to be kinked/bent.The guidewire was noted to be broken/fractured approx.183 cm from the proximal end.The guidewire ptfe was seen to be peeling approx., 48 cm from the proximal end.An assignable cause of procedural factors will be assigned to the reported and analyzed event: ¿guidewire broken/fractured during use¿ and analyzed events: ¿guidewire kinked/bent¿, ¿guidewire distal end/tip 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.Analysis of the returned device also found damage to the ptfe coated length.Scraping and peeling was evident approx., 48 cm from the proximal end and most likely occurred as a result of interaction with another device.The damage noted is consistent with backloading the proximal end of the guidewire into the distal end of the introducer and pulling it through the introducer.The analyzed event: 'guidewire ptfe coating peeling¿ will be assigned handling damage as the issue is due to handling of the product or portion of the product during the clinical procedure, upon removal of the product from the packaging, or preparation of the product prior to use.

• Brand Name: SYNCHRO-14 STRAIGHT 200-45CM
• 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: 20463332
• Report Number: 3012931345-2024-00186
• Device Sequence Number: 18356644
• Product Code: DQX
• UDI-Device Identifier: 07613252186939
• UDI-Public: (01)07613252186939(17)260404(10)0000644028
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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): 01/06/2025

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: 04/04/2026
• Device Catalogue Number: M00313020
• Device Lot Number: 0000644028
• 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: 09/25/2024
• Supplement Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 01/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2024
• 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
• Patient Sex: Unknown