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

Catalog Number	SSFT215PRE
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is 2 of 2 reports.
Event or Problem Description
It was reported during a visit to customer, the doctor reported that there was an incident in which the coating peeled off on a subject guide wire used in the early stage of the product launch.No other information was provided.
Event or Problem Description
It was reported during a visit to customer, the doctor reported that there was an incident in which the coating peeled off on a subject guide wire used in the early stage of the product launch.No other information was provided.
Additional Manufacturer Narrative
D4 gtin: corrected to ¿(b)(4).' d4 expiration date - added.H4 manufacturing date ¿ added.There are controls in the manufacturing process to ensure the product met specifications upon release.The subject guidewire device is not available; therefore, a visual inspection as well as a functional evaluation could not be performed.The reported ¿guidewire ptfe coating peeling¿ could not be confirmed, and it cannot be confirmed that the device met specification, as the device was not returned.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.It was reported that during a visit to inform the customer of the recall of synchro guidewires, the doctor reported an event in which the coating came off a synchro guidewire that had been used in the past.There was an incident in which the coating peeled off on a subject guide wire used in the early stage of the product launch.The answers to the additional questions were unknown.Guidewire ptfe coating is known to have the potential to peel during backloading of the guidewire through the introducer and also due to interaction with an under tightened torque device.It is unknown if either the introducer or the torque device were used with the guidewire.As the device was not returned and a review of all available information fails to indicate an assignable cause for the reported event, an assignable cause of undeterminable will be assigned to this complaint.This is 2 of 2 reports.

• Brand Name: SYNCHRO SELECT-14 SOFT 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: 19974072
• Report Number: 3012931345-2024-00150
• Device Sequence Number: 7057388
• Product Code: MOF
• UDI-Device Identifier: 07613327508598
• UDI-Public: (01)07613327508598(17)240428(10)0000063125
• 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): 10/24/2024

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: 04/28/2024
• Device Catalogue Number: SSFT215PRE
• Device Lot Number: 0000063125
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2024
• Supplement Date Received by Manufacturer: 10/03/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/30/2021
• 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
• Patient Sex: Unknown