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

Catalog Number	SSTD215PRE
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There are controls in the manufacturing process to ensure the product met specifications upon release.During analysis, the guidewire was noted to be kinked/bent at 90cm from the proximal end and the guidewire ptfe (polytetrafluoroethylene) coating was noted to be peeling at 55cm from the proximal end.The peeling most likely occurred as a result of interaction with another device.It is most likely the torque device was not securely fastened causing it to drag down the wire during use.The guidewire was soaked in water, the hydrophilic coating was noted to be intact, the guidewire distal tip revealed slight uneven swelling/bulge on its distal tip, when dry after approximately 10 seconds, the distal tip showed no anomaly and the swelling/bulge had disappeared.During the dimensional inspection, the od at the distal end was confirmed to be within specification when dry but when hydrated the od at the distal end was confirmed to be outside specification at 0.0182".When dry, the swelling/bulge had disappeared.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 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.Additional information provided by the customer indicated that there was no damage noted to the packaging prior to preparation of the device and was prepared as per the dfu.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.As the root cause for this issue has not yet been established, an assignable cause of undeterminable will be assigned to the as analyze ¿device has cosmetic/appearance issue¿.An assignable cause of handling damage will be assigned to the as reported/as analyzed 'guidewire kinked/bent' as well as the as analyzed 'guidewire ptfe coating peeling' as these issues are 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
The subject guidewire was returned for analysis and the device investigation revealed that subject guidewire ptfe (polytetrafluoroethylene) coating was peeled.No clinical consequences were reported to the patient due to this event.

• Brand Name: SYNCHRO SELECT-14 STANDARD PS 215CM
• Common Device Name: WIRE, GUIDE, CATHETER, NEUROVASCULATURE
• 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: 17446344
• Report Number: 3012931345-2023-00179
• Device Sequence Number: 14131228
• Product Code: MOF
• UDI-Device Identifier: 07613327508512
• UDI-Public: 07613327508512
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 08/02/2023

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: 01/29/2026
• Device Catalogue Number: SSTD215PRE
• Device Lot Number: 220231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/11/2023
• Initial Report FDA Received Date: 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2023
• 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