MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO2-14 SUPPORT STRAIGHT 215CM; WIRE, GUIDE, CATHETER

Catalog Number S2SPS14215

Device Problem Peeled/Delaminated (1454)

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

Event Date 12/06/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that coating of the guidewire (subject device) stripped off into scrub nurse's hand before wire was introduced to catheter.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.No additional information available.

Event Description

It was reported that coating of the guidewire (subject device) stripped off into scrub nurse's hand before wire was introduced to catheter.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.No additional information available.

Manufacturer Narrative

H4 manufacturing date ¿ added.D4 expiration date - added.There are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.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 that the device met specification, as the device was not returned.It was reported that the coating stripped off into scrub nurse's hand before wire was introduced to catheter.There was no additional information available.As the device was not returned for analysis and the available information fails to indicate an assignable cause for the reported event, an assignable cause of undeterminable will be assigned to the as reported 'guidewire ptfe coating peeling'.

• Brand Name: SYNCHRO2-14 SUPPORT STRAIGHT 215CM
• Type of Device: 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: 18327658
• MDR Text Key: 330575055
• Report Number: 3012931345-2023-00259
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K053268
• 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: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: S2SPS14215
• Device Lot Number: 0000065644
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2021
• 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