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	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the coating of the guidewire (subject device) came off when inserting into the introducer sheath.No clinical consequences were reported to the patient due to this event.No further information is available.
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, the guidewire tip was shaped, and the ptfe coating was examined under magnification and there was evidence of scraping/pulling of the ptfe from the proximal end towards the distal end in several places between approximately 0.8cm to 48.7cm from the proximal end.The guidewire distal section and hydrophilic coating was examined along its length with wet fingers and no anomaly was noted.The nitinol tubing proximal bond was in place.The corewire distal end was observed through the distal tip dome.A functional test was not required as the reported event was confirmed based on the device analysis.The device failed to meet specification when received for complaint investigation based on the analyzed anomalies noted to the device.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.Scraping was also evident which indicates the ptfe encountered an interaction with another device most likely from the introducer during loading the wire into the introducer.The as reported and as analyzed guidewire ptfe coating peeling 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.
Event or Problem Description
It was reported that during the procedure, the coating of the guidewire (subject device) came off when inserting into the introducer sheath.No clinical consequences were reported to the patient due to this event.No further information is available.

• 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: 12145665
• Report Number: 3012931345-2021-00111
• Device Sequence Number: 4581010
• Product Code: DQX
• UDI-Device Identifier: 04546540688774
• UDI-Public: 04546540688774
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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): 08/27/2021

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: 04/11/2024
• Device Model Number: M00326420
• Device Catalogue Number: M00326420
• Device Lot Number: 0000062137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2021
• Initial Date Received by Manufacturer: 06/16/2021
• Supplement Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 07/09/2021
• Supplement Report FDA Received Date: 08/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1