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

Model Number	GW1420040
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to the manufacturer and will be shipped to the manufacturing site for product evaluation.The investigation is currently underway.
Event or Problem Description
It was reported that after removal from the package, the guide wire appeared to be delaminated.The device was not used in the patient.
Additional Manufacturer Narrative
Review of the device history record and shipping inspection report of the involved product/lot# combination confirmed that no deviation nonconformity related to the event was found.Visual inspection of the actual sample did not find any anomaly, including a kink in its appearance.Magnifying inspection of the platinum coil section did not find any anomaly.Magnifying inspection of the stainless steel coil section did not find any anomaly.Magnifying inspection of the shaft did not find any anomaly including the peeling of the outer layer.The outer diameters of the platinum coil section, the stainless steel coil section and the shaft were measured and met specification.An attempt was made to insert the distal end of the actual sample into the hub of a factory-retained central circulatory system micro catheter and it was confirmed that the actual sample could be inserted into the headway 17 over the entire length.During the investigation, the actual sample was confirmed to have no anomaly.In addition, no anomaly was noted in the relevant production records.From the available information, the cause of this complaint could not be determined definitely.H11 - corrected data: (a1).

• Brand Name: TRAXCESS 14 GUIDEWIRE (14 IN.)
• Common Device Name: CATHETER, GUIDE WIRE
• Manufacturer (Section D): MICROVENTION, INC; 35 enterprise drive; aliso viejo, ca
• MDR Report Key: 10117086
• Report Number: 2032493-2020-00130
• Device Sequence Number: 1848506
• Product Code: MOF
• UDI-Device Identifier: 00810170012280
• UDI-Public: (01)00810170012280(11)200108(17)221231(10)200108
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K133725
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2020

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: 12/31/2022
• Device Model Number: GW1420040
• Device Catalogue Number: GW1420040
• Device Lot Number: 200108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2020
• Initial Date Received by Manufacturer: 05/07/2020
• Supplement Date Received by Manufacturer: 05/28/2020
• Initial Report FDA Received Date: 06/03/2020
• Supplement Report FDA Received Date: 06/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR