MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO-10 STRAIGHT 200CM; WIRE, GUIDE, CATHETER

Model Number	M00316310
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during the procedure while sliding the introducer over the subject guidewire the ptfe coating was peeling off.The procedure was completed successfully and there were no clinical consequences to the patient.
Event or Problem Description
It was reported during the procedure while sliding the introducer over the subject guidewire the ptfe coating was peeling off.The procedure was completed successfully and there were no clinical consequences to the patient.
Additional Manufacturer Narrative
The device was returned and the lot number was confirmed with the packaging returned with the device.During visual inspection the subject guidewire was noted to be kinked/bent at approximately 65cm, 77cm and 145cm from the proximal end.The ptfe coating was examined under magnification and the coating was peeling/peeled in multiple areas to 38cm from the proximal end.The core wire distal end was observed through the distal tip dome.The hydrophilic coating was hydrated there were no anomalies noted.The returned introducer was examined under magnification and the ptfe coating was noted on the distal tip.Functional inspection not required as the reported event was confirmed visually.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.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 reported event was confirmed during the device analysis.The device failed to meet specifications when returned.Additional information indicates there was no damage noted to the packaging prior to opening the packaging, the device was prepared for use as per the dfu, and the issue occurred during prep.The dispenser hoop was flushed before removing the guidewire and there was no resistance encountered removing the guidewire from the dispenser hoop and the introducer sheath was used with the guidewire during the insertion process and the coating issue was noted on the whole guidewire after the introducer was advanced over the wire.Analysis of the returned device found the result guidewire was kinked.Scraping and peeling of the ptfe was also evident in several sections from the proximal tip to approximately 38 cm from the proximal end and most likely occurred as a of interaction with another device.Ptfe flakes were noted on the distal end surface of the introducer.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.Ptfe flakes were also noted inside the torque device which indicates the torque device was not securely fastened around the guidewire causing it to drag down the wire during use.The as reported and as analyzed event of the guidewire ptfe coating peeling and the guidewire kinked/bent 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-10 STRAIGHT 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
• 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: 12618983
• Report Number: 3012931345-2021-00166
• Device Sequence Number: 11086799
• Product Code: DQX
• UDI-Device Identifier: 07613252187158
• UDI-Public: 07613252187158
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• 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): 02/03/2022

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: 06/28/2023
• Device Model Number: M00316310
• Device Catalogue Number: M00316310
• Device Lot Number: 0000066683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/15/2021
• Supplement Date Received by Manufacturer: 01/06/2022
• Initial Report FDA Received Date: 10/12/2021
• Supplement Report FDA Received Date: 02/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2021
• 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