MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO SELECT-14 STANDARD PS 215CM; GUIDE, WIRE, 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	05/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The device was returned for analysis and the investigation of the device revealed that the guidewire (subject device) ptfe coating was peeling.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
Review of the device history record (dhr) review confirms that the device met all material, assembly and performance specifications.The device was returned and the lot number was not confirmed as no packaging was returned with the device.During visual inspection an attempt had been made to shape the guidewire tip.The guidewire was noted to be kinked/bent at 11cm and 70cm from the proximal end.The guidewire ptfe coating was noted to be peeling in multiple areas to 40cm from the proximal end and the core wire distal end was observed through the distal tip dome.The guidewire was soaked in water.After soaking the guidewire, it was inspected wet.The hydrophilic coating was 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 functional inspection the guidewire was advanced through a flushed demonstration microcatheter, slight friction was noted as the guidewire advanced towards the distal end of the microcatheter.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 continuous flush set up and maintained throughout the procedure.No damage was noted to the packaging prior to opening, the device was confirmed to be in good condition during preparation/prior to use on the patient and was prepared as per the dfu.During analysis, the guidewire ptfe coating was noted to be peeling in multiple areas to 40cm 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 noted to be kinked/bent at 11cm and 70cm from the proximal end.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's were confirmed to be within specification when the device was both wet and dry.During the functional inspection, the guidewire was advanced through a flushed demonstration microcatheter and slight friction was noted towards the distal end of the microcatheter.An assignable cause of undeterminable will be assigned to the reported and analyzed event of the guidewire difficult to advance and to the analyzed event of the guidewire friction and device has cosmetic/appearance issue, as a review and analysis of all available information fails to indicate an assignable cause or probable assignable cause.An assignable cause of handling damage will be assigned to the analyzed damage of the guidewire ptfe coating peeling and the guidewire kinked/bent 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.

• Brand Name: SYNCHRO SELECT-14 STANDARD PS 215CM
• Common Device Name: GUIDE, WIRE, 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: 17490985
• Report Number: 3012931345-2023-00183
• Device Sequence Number: 17955184
• Product Code: MOF
• UDI-Device Identifier: 07613327508512
• UDI-Public: 07613327508512
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 08/09/2023

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: 0000220231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/18/2023
• Initial Report FDA Received Date: 08/09/2023
• 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