MAUDE Adverse Event Report: MICROVENTION INC. TRAXCESS-14; CATHETER GUIDEWIRE

Model Number	GW1420040
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after shaping the guidewire, the coding on the tip appeared different.A new traxcess guidewire was shaped and used without any problems.The issue was identified during prep, and the device was not used in the patient.
Additional Manufacturer Narrative
A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.It was stated that the device is available for evaluation, but it has not yet been returned to the manufacturer.The alleged issue could not yet be confirmed.If the device is received, an investigation will be performed and a supplemental mdr will be submitted.
Additional Manufacturer Narrative
The investigation of the returned device found the device to be damaged as described in the complaint description.Based on the investigation result, as a possible cause of this case, it was likely that pulling force was applied to the distal end of guidewire from the time the product was taken out from the holder to the time the product was used, causing the coil to elongate.However, since the details at the time of use were unknown, it was not possible to clarify the cause of occurrence.

• Brand Name: TRAXCESS-14
• Common Device Name: CATHETER GUIDEWIRE
• Manufacturer (Section D): MICROVENTION INC.; 35 enterprise; aliso viejo 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 15180373
• Report Number: 2032493-2022-00313
• Device Sequence Number: 17398764
• Product Code: MOF
• UDI-Device Identifier: 00810170012280
• UDI-Public: (01)00810170012280(11)220404(17)250331(10)220404
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K200547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2022

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: 03/31/2025
• Device Model Number: GW1420040
• Device Catalogue Number: GW1420040
• Device Lot Number: 220404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2022
• Supplement Date Received by Manufacturer: 10/13/2022
• Initial Report FDA Received Date: 08/05/2022
• Supplement Report FDA Received Date: 10/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2022
• 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 Sex: Unknown