MAUDE Adverse Event Report: MICROVENTION, INC TRAXCESS 14 GUIDEWIRE (14 IN.); CATHETER, GUIDE WIRE

Model Number	GW1420040X
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for analysis; therefore, the alleged product issue cannot be confirmed.If the device or additional information is received, microvention, inc., will issue a supplemental mdr report.
Event or Problem Description
It was reported that during the device preparation prior to use, the hydrophilic coating was observed to be peeling.There was no patient involvement.
Additional Manufacturer Narrative
The investigation of the returned traxcess device did not find any condition consistent with the hydrophilic coating issue described in the reported event.Review of the manufacturing record and the shipping inspection record of the involved product code/lot# combination confirmed that there was not any indication of anomaly in them.A search of the complaint file found no other similar report with the involved product code/lot# combination from other facilities.

• Brand Name: TRAXCESS 14 GUIDEWIRE (14 IN.)
• Common Device Name: CATHETER, GUIDE WIRE
• 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: 13488164
• Report Number: 2032493-2022-00052
• Device Sequence Number: 12064790
• Product Code: MOF
• UDI-Device Identifier: 00810170014864
• UDI-Public: (01)00810170014864(11)210121(17)231231(10)210121
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K133725
• 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): 01/14/2022

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: 12/31/2023
• Device Model Number: GW1420040X
• Device Catalogue Number: GW1420040X
• Device Lot Number: 210121
• 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: 01/14/2022
• Supplement Date Received by Manufacturer: 02/16/2022
• Initial Report FDA Received Date: 02/08/2022
• Supplement Report FDA Received Date: 03/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2021
• 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