MAUDE Adverse Event Report: MICROVENTION, INC TRAXCESS 14 GUIDEWIRE; WIRE, GUIDE, CATHETER

Model Number	GW1420040
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of the traxcess was deformed.Clarification noted it seemed that the coating was uneven or inadequate and damaged in the first few centimeters.A new traxcess was used.There was no reported impact or harm to the patient.The reporter has no other information.
Additional Manufacturer Narrative
Although expected, the reported device has not been received into microvention's complaint system for evaluation.Device history record review and lot history trending will be provided with the final report as well as the device evaluation and complaint investigation.
Additional Manufacturer Narrative
A review of the manufacturing history record and the shipping inspection record confirmed there were no anomaly in them.A search of the complaint file found no other similar report with the involved product code/lot number combination from other facilities.The information originally provided indicated that the product was being returned for evaluation.Updated information has been received which confirms that the device is not available to be returned.The device was discarded at the user facility.Procedural or medical imaging was not provided.The deformed tip and damaged coating could not be confirmed.

• Brand Name: TRAXCESS 14 GUIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): MICROVENTION, INC; 35 enterprise drive; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 15164182
• Report Number: 2032493-2022-00303
• Device Sequence Number: 14667280
• Product Code: DQX
• UDI-Device Identifier: 00810170012280
• UDI-Public: (01)00810170012280(11)220318(17)250228(10)220318
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P133725
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2022

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: 02/28/2025
• Device Model Number: GW1420040
• Device Catalogue Number: GW1420040
• Device Lot Number: 220318
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2022
• Supplement Date Received by Manufacturer: 10/13/2022
• Initial Report FDA Received Date: 08/04/2022
• Supplement Report FDA Received Date: 10/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown