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

Model Number	M00326110
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2020
Type of Reportable Event	Malfunction
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.During visual inspection, a torque device was attached to the guidewire, 33cm from the distal end.The torque device was removed, and the guidewire was examined under magnification with wet fingers.The guidewire distal section and hydrophilic coating was examined along its length.No anomalies were observed with the hydrophilic coating.The guidewire ptfe (polytetrafluoroethylene) coating was noted to be damaged and peeled/scraped 34cm from the proximal section, between approximately 34cm to 36cm section.The torque device was examined under magnification and no anomaly was noted.During functional testing, the guidewire was kept hydrated per the device directions for use.The guidewire was loaded, and advanced through the proximal end of the demonstration of the sl-10 microcatheter without issue.The guidewire was advanced out of the microcatheter distal end without any resistance.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 indicates there was no damage noted to the packaging prior to opening the packaging, the device was confirmed to be in good condition during preparation/prior to use on the patient, the device was prepared for use as per the directions for use, continuous flush was maintained throughout the clinical procedure, and the patient¿s anatomy was average tortuous.A chikai 14 and sl-10 microcatheter were used in conjunction with the synchro2-14 guidewire.Analysis of the returned device found approximately 2cm of the guidewire ptfe coating was peeled/scraped off approximately 34cm from the proximal end, but is unlikely to have caused or contributed to the reported event as this section of the guidewire would not have entered the microcatheter.It is probable the guidewire ptfe coating was damaged when the torque device was being attached as the damage was noted in the section when the torque device was removed.An assignable cause of procedural factors will be assigned to the as analysed issue guidewire ptfe coating peeling.The initial reported event guidewire difficult to insert was not confirmed based on the analysis, as the device was inserted and advanced through the demonstration sl-10 microcatheter without any issue.Therefore, an assignable cause of not confirmed was assigned to the initial reported complaint.
Event or Problem Description
Analysis of the returned device found that the guidewire was broken, and the ptfe (polytetrafluoroethylene) coating was peeled off.There was no clinical consequence to the patient as a result of this event.

• Brand Name: SYNCHRO2-14 SOFT 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: 10760428
• Report Number: 3012931345-2020-00174
• Device Sequence Number: 17055266
• Product Code: DQX
• UDI-Device Identifier: 04546540688736
• UDI-Public: 04546540688736
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 10/30/2020

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: 03/01/2023
• Device Model Number: M00326110
• Device Catalogue Number: M00326110
• Device Lot Number: 0000041949
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/07/2020
• Initial Report FDA Received Date: 10/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1