MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO-10 STRAIGHT 200CM; WIRE, GUIDE, CATHETER

Catalog Number	M00316310
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the automated mes (manufacturing execution system) system 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 could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.It was reported that the subject guidewire detached in a non-stryker microcatheter during cannulation.Additional information provided by the customer indicated that there were no anomalies noted to the device during initial inspection and preparation, the device was prepared as per the dfu, the dispenser hoop was flushed before removing the guidewire and there was no resistance encountered removing the guidewire from the dispenser hoop, the guidewire tip was not shaped, continuous flush was maintained for the duration of the procedure, the patient's anatomy was tortuous, the inner diameter of the microcatheter was 0.013in, and a different microcatheter with an inner diameter of 0.0165in was used to finish the procedure.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.
Event or Problem Description
It was reported that during cannulation, the tip of the guidewire (subject device) detached in a non-stryker microcatheter.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.The patient condition following procedure is stable.
Event or Problem Description
It was reported that during cannulation, the tip of the guidewire (subject device) detached in a non-stryker microcatheter.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.The patient condition following procedure is stable.
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 k023700 in accordance with the global unique device identification database (gudid).

• Brand Name: SYNCHRO-10 STRAIGHT 200CM
• 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: 17931944
• Report Number: 3012931345-2023-00226
• Device Sequence Number: 6368467
• Product Code: DQX
• UDI-Device Identifier: 07613252187158
• UDI-Public: 07613252187158
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K023700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,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: 01/09/2025
• Device Catalogue Number: M00316310
• Device Lot Number: 0000213984
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2023
• Supplement Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 10/13/2023
• Supplement Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2023
• 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: APOLLO MICROCATHETER (NON-STRYKER).
• Patient Sex: Unknown