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	08/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not yet received for evaluation.
Event or Problem Description
It was reported that during the procedure, the guidewire (subject device) was found to have particles of the coating peeling off while inserting into the introducer.The subject device was removed and discarded.The subject device was replaced, and the procedure was completed successfully.There were no clinical consequences to the patient due to this event.
Additional Manufacturer Narrative
The device was returned and the lot number was confirmed with the packaging returned with the device.During visual inspection, an attempt had been made to shape the tip of the guidewire.The device was returned loaded into the introducer 83.6cm from the distal end and 107.9cm from the proximal end.The ptfe coating was examined under magnification and there was no damage noted to the ptfe at the distal end of the introducer but and the ptfe was peeling/peeled off in multiple places along its proximal section from 0.2cm to 107.9cm from the proximal end.A flake of ptfe was visible inside the hub of the introducer.The introducer was inspected, and ptfe shavings were present inside the distal end of the introducer and ptfe flakes were visible on the surface of the introducer.The surface at the distal end of the introducer appeared rough.The core wire distal end was observed through the distal tip dome.The hydrophilic coating was hydrated and inspected, there were no anomalies noted.A functional test was not required as the defect was visually confirmed.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 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 defect was confirmed during the device analysis.The device failed to meet specifications when returned.Additional information provided by the customer indicated that 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 as per the directions for use and continuous flush was set up and maintained throughout the clinical procedure.There was no patient involvement and the device was not in use on the patient at the time of the event.The physician claimed the wire introducer could have caused the issue.Analysis of the returned device found the ptfe was loaded into the guidewire.The tip of the guidewire appeared to have been shaped.The ptfe was peeled off or peeling between approximately 0.2cm to 107.9cm from the proximal end.Shaving(s) and flake(s) of ptfe were present inside the hub of the introducer inside the distal end of the introducer and on its surface and is consistent with damage caused by back loading the guidewire into the introducer sheath.The as reported and as analyzed event of the guidewire ptfe coating peeling has been 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.
Event or Problem Description
It was reported that during the procedure, the guidewire (subject device) was found to have particles of the coating peeling off while inserting into the introducer.The subject device was removed and discarded.The subject device was replaced, and the procedure was completed successfully.There were no clinical consequences to the patient due to this event.

• 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: 12479028
• Report Number: 3012931345-2021-00149
• Device Sequence Number: 3848191
• Product Code: DQX
• UDI-Device Identifier: 07613252187158
• UDI-Public: 07613252187158
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 11/23/2021

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: 03/28/2023
• Device Model Number: M00316310
• Device Catalogue Number: M00316310
• Device Lot Number: 0000061360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/25/2021
• Supplement Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 09/16/2021
• Supplement Report FDA Received Date: 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2021
• 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