MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO SELECT-14 STANDARD PS 300CM; WIRE, GUIDE, CATHETER

Model Number	SSTD300PRE
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the results of the device history record (dhr) review, there is no indication that the device, labeling, or packaging failed to meet its specifications when released.During visual inspection, the guidewire was noted to have a torque device attached at 27cm from the proximal end, the guidewire was noted to be kinked/bent at 234.5cm from the proximal end, the distal tip of the guidewire was noted to be kinked/bent, the guidewire ptfe coating was examined under magnification and there was evidence of damage to the coating.Peeling of the ptfe coating was noted from the proximal end towards the distal end in several places to approximately 27cm from the proximal end, and the core wire distal end was observed through the distal tip dome.Functional test was not required.The reported complaint was confirmed based on analysis; the device failed to meet specifications 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.The device was returned, and the synchro guide wire was visually inspected.The guide wire was found kinked/bent near the distal end.In the case of this complaint, it is possible that during the removal of the device from the hoop or packaging, the distal end of the synchro was slightly damaged resulting in the reported event.This cannot be conclusively determined.Additional information did not indicate any issue with the preparation of the device.An assignable cause of 'handling damage' will be assigned to the to as reported defects 'guidewire distal end kinked/bent' and 'device or component could not be removed from packaging' and the as analyzed codes of 'guidewire kinked/bent', 'guidewire distal end kinked/bent', and 'guidewire ptfe coating peeling' as the issue is most likely 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
Analysis of the returned device found the subject guidewire ptfe coating was peeling/peeled.There were no clinical consequences to the patient reported as a result of this event.

• Brand Name: SYNCHRO SELECT-14 STANDARD PS 300CM
• 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: 12712707
• Report Number: 3012931345-2021-00179
• Device Sequence Number: 4775458
• Product Code: MOF
• UDI-Device Identifier: 07613327508529
• UDI-Public: 07613327508529
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K202522
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/28/2021

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: 10/06/2023
• Device Model Number: SSTD300PRE
• Device Catalogue Number: SSTD300PRE
• Device Lot Number: 0000052718
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/26/2021
• Initial Report FDA Received Date: 10/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1