MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO-14 STRAIGHT 300-35CM; WIRE, GUIDE, CATHETER

Catalog Number	M00313310
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection the guidewire was returned broken/fractured in 2 segments: 295cm from the proximal end and 5cm from the distal end.The guidewire was noted to be kinked/bent at 157cm.The guidewire distal coil wire was noted to be stretched.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 broken/fractured with the platinum wire exposed.The core wire distal end was observed through the distal tip dome.Functional inspection was not required.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 event was confirmed based on the damage noted to the returned device.The device failed to meet specification when returned for analysis.Additional information provided by the customer indicated that there was no damage noted to the packaging prior to opening the packaging, the device was confirmed to be in good condition during preparation/prior to use on the patient, the device was prepared for use as per the directions for use, there was no resistance encountered removing the guidewire from the dispenser hoop, continuous flush was set up and maintained throughout the clinical procedure.There was no friction/resistance encountered during the procedure.The patient¿s anatomy was not tortuous.During analysis of the returned device found the guidewire was broken in two fragments.Both fragments were found to have the nitinol tubing broken/fractured with the core wire and platinum coil exposed and stretched which indicates the device encountered a significant manipulation during the procedure or removal from the patient.The guidewire was also noted to be kinked/bent at 157cm from the proximal end.An assignable cause of procedural factors will be assigned to the reported event ¿guidewire distal tip stretched¿ as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.An assignable cause of procedural factors will be assigned to the analysed events ¿guidewire kinked/bent¿, ¿guidewire distal tip stretched¿ and ¿guidewire distal tip broken/fractured during use' as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.
Event or Problem Description
The subject device was returned for analysis and it was discovered that the guidewire (subject device) distal tip broken/fractured during use.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
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
The subject device was returned for analysis and it was discovered that the guidewire (subject device) distal tip broken/fractured during use.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: SYNCHRO-14 STRAIGHT 300-35CM
• 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: 18037479
• Report Number: 3012931345-2023-00232
• Device Sequence Number: 8268928
• Product Code: DQX
• UDI-Device Identifier: 07613252186946
• UDI-Public: 07613252186946
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• 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: 12/18/2024
• Device Catalogue Number: M00313310
• Device Lot Number: 0000209432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2023
• 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: 10/31/2023
• Supplement Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2022
• 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 Age: 72 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Race: Asian