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

Model Number	SSTD215PRE
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the results of the dhr (device history record) review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.During a visual test, the guidewire distal tip was shaped, the guidewire was noted to be kinked/bent at 40cm, 47cm, 74cm and 90cm from the proximal end, the guidewire ptfe (polytetrafluoroethylene) coating was noted to be peeling in multiple areas to 156cm from the proximal end, and the core wire distal end was observed through the distal tip dome.During a functional test the guidewire was successfully advanced through the flushed returned balloon catheter, no anomalies were 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 reported complaint could not be confirmed since the reported issue was unknown/unclear.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 was noted to be kinked/bent at 40cm, 47cm, 74cm and 90cm from the proximal end and the guidewire ptfe coating was noted to be peeling in multiple areas to 156cm from the proximal end.The peeling most likely occurred as a result of interaction with another device.The damage noted is consistent with backloading the proximal end of the guidewire into the distal end of the introducer and pulling it through the introducer.During the functional inspection the guidewire was successfully advanced through the flushed returned balloon catheter.An assignable cause of not confirmed will be assigned to the as reported 'device problem unknown/unclear'.The as analyzed 'guidewire kinked/bent' and 'guidewire ptfe coating peeling' will 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
The guidewire subject device was returned for analysis and it was discovered that the ptfe (polytetrafluoroethylene) was noted to be peeling in multiple areas.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• 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: 15443725
• Report Number: 3012931345-2022-00176
• Device Sequence Number: 14635111
• 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): 09/19/2022

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: 07/31/2024
• Device Model Number: SSTD215PRE
• Device Catalogue Number: SSTD215PRE
• Device Lot Number: 0000069870
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/06/2022
• Initial Report FDA Received Date: 09/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TRANSFORM SUPER BALLOON (STRYKER)
• Patient Sex: Unknown