MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO SELECT-14 STANDARD PS 215CM; WIRE, GUIDE, CATHETER

Model Number	SSTD215PRE
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record (dhr) confirms that the device met all material, assembly and performance specifications.During visual inspection, the guidewire was found kinked/bent at the proximal end.The ptfe coating was damaged in multiple areas to the proximal end.During functional testing, the hydrophilic coating was hydrated and there were no anomalies noted.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 device was returned, and it was confirmed that the ptfe coating was peeled in several location to the proximal end of the device.This damage is indicative of an under tightened torque device, causing scraping to the ptfe coating during use.An assignable cause of handling damage was assigned to the reported events guidewire coating issue and to the analyzed events guidewire kinked/bent and guidewire ptfe coating peeling, as it is probable that the damage occurred as a result of handling of the device during use.
Event or Problem Description
Analysis of the returned device found that the ptfe coating was peeled in several locations to the proximal end of the subject guidewire.There were no clinical consequences to the patient reported as a result of this event.

• Brand Name: SYNCHRO SELECT-14 STANDARD PS 215CM
• 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: 12686558
• Report Number: 3012931345-2021-00174
• Device Sequence Number: 1364225
• Product Code: DQX
• UDI-Device Identifier: 07613327508512
• UDI-Public: 07613327508512
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 10/22/2021

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: 11/23/2023
• Device Model Number: SSTD215PRE
• Device Catalogue Number: SSTD215PRE
• Device Lot Number: 0000055064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/27/2021
• Initial Report FDA Received Date: 10/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1