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

Model Number	GW1420040
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: the inr team discovered, before the procedure, a thread like foreign body on the wire.The wire had not been in touch with anything before this was discovered.Patient status is good.
Additional Manufacturer Narrative
The device was stated to be available for return to the manufacturer for evaluation but has not yet been returned despite a device return attempt.Ongoing attempts will be made for the device return.The alleged product issue/event as described could not be confirmed.If the device is received at a later date, an investigation will be performed and a supplemental mdr will be submitted.
Event or Problem Description
As reported: the inr team discovered, before the procedure, a thread like foreign body on the wire.The wire had not been in touch with anything before this was discovered.Patient status is good.
Additional Manufacturer Narrative
Correction: brand name in d1 was corrected.1.Actual sample upon receipt: traxcess main body.Blue foreign substance.2.Visual and magnifying inspections: [traxcess main body] in the area from 0 to approx.30 mm from the distal end, a curve, an elongation of coil (opened coil pitch), and a kink (gaps in coil pitch) were observed.From this, it was inferred that the curved part was caused by a shaping process.The elongation of coil and the kink were assumed to have been caused by some pulling and bending force.Therefore, the above-mentioned damage was considered to have no relation with this complaint.Peeling of coating was interspersed in the area approx.460 mm-1717 mm from the distal end.The area approx.460 mm -550 mm from the distal end was examined arbitrary.The peeling had occurred semi-circumferentially.[blue foreign substance] it was tangled.Scrape-like marks were observed.3.Component analysis of the blue foreign substance (ft-ir*) the peaks of the foreign substance were similar to those of the coating component.*ft-ir (fourier transform infrared spectroscopy method): an analysis method to specify the molecular structure of an object by analyzing the spectrum obtained by irradiating the target with infrared rays.Since the wavelength of the infrared absorbed is almost unique to each substance, qualitative analysis of the substance is possible by comparing it with the standard sample of infrared absorption spectrum.From this, the foreign substance was inferred to be the coating that had peeled off from the actual sample.4.Confirmation of missing portion: since the foreign substance was tangled, it was not possible to confirm if there was any deficient portion in the coating layer.5.Dimensional inspection: the outside diameter of the undamaged part of the traxcess main body was within our control standard.No anomaly was found.7.Past simulation test: insert a traxcess sample into an attached metal inserter and bring the shaft of the traxcess into contact with the tip edge of the metal inserter.With the traxcess in contact with the tip edge, it was hold bent and pulled out so that an abrasion load was applied.As a result, peeling of coating occurred on the shaft section.In the manufacturing process, the following operations and inspections are performed to maintain the quality.After the coating of outer layer, 100% magnifying inspection of the shaft is performed to confirm that there is no anomaly in the appearance such as peeling of outer layer.At the time of shipping inspection, magnifying inspection is performed per lot number basis to assure that there is no anomaly in the appearance such as peeling of outer layer.Based on the investigation result, no anomaly was found in the dimensions of the actual sample.From the results of the condition of the actual sample and the simulation test result, it was considered that the coating peeled off due to abrasion load applied by some hard object (e.G., metal object) having come into contact with the surface of the shaft section.However, it was not possible to identify such a hard object from the condition of the actual sample.

• Brand Name: TRAXCESS GUIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 19280696
• Report Number: 2032493-2024-00370
• Device Sequence Number: 7649072
• Product Code: DQX
• UDI-Device Identifier: 00810170012280
• UDI-Public: (01)00810170012280(11)230801(17)260731(10)230801
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K080863
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2024

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: 07/31/2026
• Device Model Number: GW1420040
• Device Lot Number: 230801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2024
• Supplement Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2023
• 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