MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO-14 STRAIGHT 200-45CM; WIRE, GUIDE, CATHETER

Catalog Number	M00313020
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the guidewire (subject device) fractured during use and the un-retrieved piece of guidewire remained in the patient.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
B1 adverse event/product problem - corrected - no adverse event or product problem b5 executive summary - updated d4 expiration date - added h1 type of reportable event - corrected - no serious injury or malfunction h4 manufacturing date ¿ added.H3 device evaluated by mfg ¿updated h3 summary attached - updated h6 clinical signs code grid ¿ clinical code ¿ updated.There are controls in the manufacturing process to ensure the product met specifications upon release.The device was returned, and the reported lot number was not confirmed as the packaging was not returned with the device.During visual inspection, the guidewire was returned in two fragments.(189.9cm proximal fragment and 9.1cm distal fragment).The guidewire was noted to be kinked at 59.8cm.The proximal fragment was inspected, and the nitinol tubing was broken/fractured with the core wire exposed and broken.The distal fragment was inspected, and the nitinol tubing was seen to be broken with the platinum wire exposed and stretched at approximately 9.1cm from the distal tip.The core wire distal end was observed through the distal tip dome.Functional testing was not completed due to device condition.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 confirmed based on analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.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, continuous flush was set up and maintained throughout the clinical procedure and the patients anatomy was somewhat tortuous.The guidewire returned in two fragments.The guidewire was also seen to be kinked and the distal tip was stretched.An assignable cause of handling damage will be assigned to the as reported event of guidewire broken/fractured during preparation since it is most likely that this damage occurred due to handling of delivery wire during the clinical procedure.An assignable cause of handling damage will be assigned to the as analyzed event of guidewire broken/fractured during preparation, guidewire kinked/bent and guidewire distal tip stretched since it is most likely that this damage occurred due to handling of delivery wire during the clinical procedure.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.
Event or Problem Description
It was reported that during the procedure, the guidewire (subject device) fractured during use and the un-retrieved piece of guidewire remained in the patient.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.Additional information received from complaint intake center on 23-oct-2023, clarified that subject guidewire had fractured outside the patient.
Additional Manufacturer Narrative
We have addressed the fda request, received via email on 14 june 2024: ¿upon review, we have determined that the device identification information about the suspect medical devices conflicts with the data submitted to the global unique device identification database (gudid)." "discrepancies were noted in the information included for some or all of the device identification fields of the electronic equivalent of the fda form 3500a compared to the information included for the corresponding fields in the gudid." "additionally, the ¿unique device identifier (udi) #¿ field on the fda form 3500a should contain the entire udi number including the di and pi fields, all numbers, letters, parentheses, and symbols.Please verify that you have included the entire udi in the ¿unique device identifier (udi) #¿ field on the 3500a." 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 k032146 to k002907 in accordance with the global unique device identification database (gudid).
Event or Problem Description
It was reported that during the procedure, the guidewire (subject device) fractured during use and the un-retrieved piece of guidewire remained in the patient.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.Additional information received from complaint intake center on (b)(6) 2023, clarified that subject guidewire had fractured outside the patient.

• Brand Name: SYNCHRO-14 STRAIGHT 200-45CM
• 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: 17911797
• Report Number: 3012931345-2023-00223
• Device Sequence Number: 6653358
• Product Code: DQX
• UDI-Device Identifier: 07613252186939
• UDI-Public: 07613252186939
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K002907
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/12/2025
• Device Catalogue Number: M00313020
• Device Lot Number: 0000308584
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/20/2023
• Supplement Date Received by Manufacturer: 10/23/2023; 08/14/2024
• Initial Report FDA Received Date: 10/11/2023
• Supplement Report FDA Received Date: 11/08/2023; 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 2FR ANGLED PROGREAT MICROCATHETER (TERUMO)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown