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	05/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Analysis of the returned subject guidewire device revealed that the nitinol tubing of the subject guidewire was broken/fractured during use.There were no clinical consequences to the patient reported as a result of this event.
Additional Manufacturer Narrative
There are controls in the manufacturing process to ensure the product met specifications upon release.Analysis of the returned subject guidewire device found that the tip of the subject guidewire appeared to have been shaped.The subject guidewire was severely kinked/bent 13.4cm and 34.6cm from the distal end and slightly kinked/bent approximately 21cm and 29cm.The kink/bend noted at 13.4cm from the distal end was further inspected and the nitinol tubing was broken with the core wire exposed but not broken.The kink/bend noted at 34.6cm from the distal end was further inspected and the tail over the proximal bond joint was broken with a section of the torn tail still attached to the core wire with dried blood present 34.8cm from the distal end.The core wire visible inside tip dome.The subject guidewire hydrophilic coating was hydrated and there were no other anomalies noted.The functional testing could not be performed due to the condition of the returned subject guidewire device.The event was confirmed based on the damage noted to the returned subject guidewire device.The subject guidewire 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.Additional information provided by the customer indicated that there was no damage noted to the packaging prior to opening the packaging.There was no resistance encountered removing the subject guidewire from the dispenser hoop.The subject guidewire device was prepared for use as per the directions for use.The subject guidewire device was confirmed to be in good condition during preparation/prior to use on the patient.Other devices used in the procedure in conjunction with the subject guidewire device(s) were cat6 catheter and xt27 microcatheter.The subject guidewire tip was not shaped.An introducer sheath was used to facilitate the introduction of the subject guidewire into the microcatheter.A torque device was used to facilitate directional manipulation of the subject guidewire and there was no difficulty rotating the subject guidewire using the torque device.The subject guidewire was torqued 2 times.The patient¿s anatomy was reported to be severely tortuous which most likely contributed to the reported event.Analysis of the returned subject guidewire device found the tip of the subject guidewire appeared to have been shaped.The subject guidewire was severely kinked/bent 13.4cm and 34.6cm from the distal end and slightly kinked/bent approximately 21cm and 29cm.The kink/bend noted at 13.4cm from the distal end was further inspected and the nitinol tubing was broken with the core wire exposed but not broken.The kink/bend noted at 34.6cm from the distal end was further inspected and the tail over the proximal bond joint was broken with a section of the torn tail still attached to the core wire with dried blood present 34.8cm from the distal end.The condition of the returned subject guidewire indicates the device encountered a significant force during use to have caused such damage.An assignable cause of procedural factors will be assigned to the as reported ¿ guidewire distal end/tip kinked/bent¿ and as analysed ¿ guidewire distal end/tip kinked/bent¿, ¿ guidewire kinked/bent¿, ¿ guidewire broken/fractured during use¿ since this issue appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural and/or anatomical factors during use.

• 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: 20173617
• Report Number: 3012931345-2024-00165
• Device Sequence Number: 8031985
• 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
• Report Date (Section B): 09/09/2024

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: 02/18/2025
• Device Catalogue Number: M00313310
• Device Lot Number: 0000225869
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2024
• Initial Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2023
• 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: 8F GUIDER SOFT TIP (STRYKER); CAT 6 CATHETER (STRYKER); XT27 MICROCATHETER (STRYKER)
• Patient Age: 62 YR
• Patient Sex: Unknown
• Patient Race: Asian