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

Catalog Number SSTD215STR

Device Problem Peeled/Delaminated (1454)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/24/2024

Event Type  malfunction  

Event Description

It was reported that when the subject guidewire was removed from the dispenser coil, hydrophilic coating on the tip of the subject guidewire was peeled off.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

Manufacturer Narrative

H3 other text : the device is not available to the manufacturer.

Manufacturer Narrative

H4 manufacturing date ¿ added.D4 expiration date - added.D4 lot # - corrected from 528636 to 0000528636.There are controls in the manufacturing process to ensure the product met specifications upon release.The visual and functional inspections were not performed due to 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.The reported complaint was unable to be confirmed and it cannot be confirmed if the device met specification, as the device was not returned.It was reported that when removed from the dispenser coil, the tip was peeled off.Additional information provided by the customer indicated that it was the hydrophilic coating that was peeled off.It is probable that the hydrophilic coating was damaged during removal from the dispenser hoop, as this coating would have been hydrated and activated in the hoop prior to removal, however this cannot be definitively determined.The device was not returned for analysis, and a review of all information fails to indicate an assignable cause for the reported event ¿hydrophilic coating peeling', therefore an assignable cause of undeterminable will be assigned to this complaint.

Event Description

It was reported that when the subject guidewire was removed from the dispenser coil, hydrophilic coating on the tip of the subject guidewire was peeled off.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: SYNCHRO SELECT-14 STANDARD ST 215CM
• Type of Device: 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: 18713531
• MDR Text Key: 336062649
• Report Number: 3012931345-2024-00025
• Device Sequence Number: 1
• Product Code: MOF
• UDI-Device Identifier: 07613327508499
• UDI-Public: 07613327508499
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K202522
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SSTD215STR
• Device Lot Number: 0000528636
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1