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

Model Number	SSFT215PRE
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an endovascular procedure, when the subject guidewire was used to guide the microcatheter, the hydrophilic polymer coating of the subject guidewire was peeled off.The procedure was completed successfully by replacing the device.No clinical consequences were reported to the patient due to this event.
Event or Problem Description
It was reported that during an endovascular procedure, when the subject guidewire was used to guide the microcatheter, the hydrophilic polymer coating of the subject guidewire was peeled off.The procedure was completed successfully by replacing the device.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added h3 device evaluated by mfg ¿updated h3 summary attached - updated d4 expiration date - added there are controls in the manufacturing process to ensure the product met specifications upon release.The device was returned and the lot number was confirmed with the packaging.During visual inspection, the guidewire was found to be severely kinked/bent 27 cm from the distal end.The guidewire was found to be kinked/bent 49 cm from the proximal end.The core wire distal end was observed through the distal tip dome.The guidewire ptfe coating was noted to be peeling in multiple areas to 56 cm from the proximal end.The hydrophilic coating was hydrated and there were no anomalies noted.During functional inspection, the device was hydrated and there were no anomalies noted to the outer coating of 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 event was not confirmed based on the damage noted to the returned device.However, the device failed to meet specification when returned for analysis.Additional information provided by the customer indicates that the coating was probably peeled off when it was inserted in the introducer.There was no damage noted to the packaging prior to opening the packaging, the device was confirmed to be in good condition during preparation/prior to use on the patient, the device was prepared for use as per the directions for use, continuous flush was set up and maintained throughout the clinical procedure.During analysis, the guidewire was found to be severely kinked/bent, the ptfe coating was noted to be peeling in multiple areas, the peeling most likely occurred as a result of interaction with another device.There were no anomalies noted with the hydrophilic coating.Therefore not confirmed will the assigned to the as reported event of hydrophilic coating peeling.The as analysed events of 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.

• Brand Name: SYNCHRO SELECT-14 SOFT 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
• 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: 14594277
• Report Number: 3012931345-2022-00121
• Device Sequence Number: 12145025
• Product Code: MOF
• UDI-Device Identifier: 07613327508598
• UDI-Public: 07613327508598
• 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,Followup
• Report Date (Section B): 08/31/2022

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: SSFT215PRE
• Device Catalogue Number: SSFT215PRE
• Device Lot Number: 0000069923
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2022
• Supplement Date Received by Manufacturer: 08/08/2022
• Initial Report FDA Received Date: 06/03/2022
• Supplement Report FDA Received Date: 08/31/2022
• 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: SL-10 MICROCATHETER (STRYKER); SL-10 MICROCATHETER (STRYKER)
• Patient Sex: Unknown