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

Catalog Number	S2SPS14215
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 other text : the device is not available to the manufacturer.
Event or Problem 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 or Problem 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.
Additional 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'.
Additional Manufacturer Narrative
We have addressed the fda request, received via email on 8 july 2024: upon review, we have determined that the information about the suspect medical devices involved in the reported events, specifically the unique device identifier (udi) information in section d of the fda form 3500a, is incorrect.Please note that the global unique device identification database (gudid) is the master data repository for device identification information.Data submitted to gudid must match the device identification data submitted for devices involved in mdr reportable events.In addition, please ensure that device identification data submitted in the suspect medical device section of the fda form 3500a matches the device identification data in the gudid.We have reviewed the device identifier (di) and confirm that it is accurate and in alignment with the hl7 specifications released in 2017.Additionally, the 510(k) number has been corrected from k053268 to k190843 in accordance with the global unique device identification database (gudid).
Event or Problem 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.

• Brand Name: SYNCHRO2-14 SUPPORT STRAIGHT 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: 18327658
• Report Number: 3012931345-2023-00259
• Device Sequence Number: 7358888
• Product Code: DQX
• UDI-Device Identifier: 07613327459630
• UDI-Public: 07613327459630
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K190843
• 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,Followup
• Report Date (Section B): 08/14/2024

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: 06/09/2024
• Device Catalogue Number: S2SPS14215
• Device Lot Number: 0000065644
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/12/2024; 08/13/2024
• Initial Report FDA Received Date: 12/14/2023
• Supplement Report FDA Received Date: 02/15/2024; 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2021
• 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