MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO2-14 STANDARD PRE-SHAPED 200CM; WIRE, GUIDE, CATHETER

Model Number	M00326420
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during procedure, the subject guide wire got stuck inside the micro catheter.When withdrawn from patient¿s anatomy it looked like the outer part was broken and inner part was ripped.The physician replaced with new devices and procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
Based on the results of the dhr review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.The guide wire was returned with an axs offset micro catheter.The lot number was not confirmed as the packaging was not returned with the device.On visual inspection, the guide wire hydrophilic coating was broken 197cm from the proximal end and the core wire was exposed.Bubbles with uncollapsed dome were present on the hydrophilic coating from 192cm from the proximal end.The guide wire distal tip was broken and stretched 199cm from the proximal end.The guide wire distal section and hydrophilic coating was examined along its length with wet fingers.The coating was present on the guide wire and no anomaly was noted up to 192cm from the proximal end.The guide wire ptfe coating was examined under magnification and no anomaly was noted.On functional inspection an attempt was made to remove the remainder of the guide wire from the returned axs offset micro catheter but it remained jammed 104.5cm from the proximal end of the micro catheter.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 the dispenser hoop was flushed before removing the guide wire, there was no resistance encountered removing the guide wire from the dispenser hoop, there were no other difficulties encountered during the usage of the device that could have contributed to the issue, the guide wire tip was not shaped, the catheter was flushed to facilitate the guide wire insertion and the guide wire was inserted into the micro catheter prior to the micro catheter being inserted into the guide catheter.The wire was stuck in the catheter.Out of the patient they removed the wire out of the catheter and that is where the wire was ripped apart.Guide wire looks like the outer part is broken and inner part is ripped.The device was returned and the hydrophilic coating was broken and the core wire was broken and stretched at the distal end.The distal end of the guide wire remained jammed in the returned micro catheter.Additional information indicates the device was damaged during removal of the guide wire from the catheter outside the patient.An assignable cause of procedural factors will be assigned to the reported and analyzed guide wire jammed and guide wire broken/fractured during use in addition to the analyzed guide wire distal end stretched, guide wire distal tip broken/fractured during use and guide wire hydrophilic coating surface rough 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 procedure, the subject guide wire got stuck inside the micro catheter.When withdrawn from patient¿s anatomy it looked like the outer part was broken and inner part was ripped.The physician replaced with new devices and procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: SYNCHRO2-14 STANDARD PRE-SHAPED 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
• MDR Report Key: 10705600
• Report Number: 3012931345-2020-00158
• Device Sequence Number: 2953942
• Product Code: DQX
• UDI-Device Identifier: 04546540688774
• UDI-Public: 04546540688774
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 12/03/2020

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: 04/20/2023
• Device Model Number: M00326420
• Device Catalogue Number: M00326420
• Device Lot Number: 44276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2020
• Initial Date Received by Manufacturer: 10/02/2020
• Supplement Date Received by Manufacturer: 11/20/2020
• Initial Report FDA Received Date: 10/20/2020
• Supplement Report FDA Received Date: 12/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AXS OFFSET MICROCATHETER (STRYKER); AXS OFFSET MICROCATHETER (STRYKER)