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 08/21/2023

Event Type  malfunction  

Event Description

It was reported that during the procedure the operator retrieved the subject guidewire and attempted to insert it again into the microcatheter using the introducer, but a thread-like substance was observed that looked like peeling of the coating.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

Manufacturer Narrative

There are controls in the manufacturing process to ensure the product met specifications upon release.Visual and functional inspections were not conducted 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.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.Additional information provided by the customer indicated that the device was confirmed to be in good condition during preparation/prior to use on the patient and was prepared for use as per the dfu, the guidewire tip was shaped 45 degrees, the model and inner diameter of the microcatheter used in the procedure was unknown, flush was given inside the microcatheter when the guidewire was inserted, and the introducer was used when inserting the guidewire.While there are a number of potential causes for the reported issue, because review of available information failed to identify a definitive cause and the device was not returned for analysis, an assignable cause of undeterminable was assigned to this complaint.H3 other text : the device is not available to the manufacturer.

• 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: 17734180
• MDR Text Key: 323256161
• Report Number: 3012931345-2023-00208
• 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
• Report Date: 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2023
• 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: 0000235054
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2023
• 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
• Treatment: MICROCATHETER (UNKNOWN)