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

Model Number GW1420040

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/08/2023

Event Type  malfunction  

Manufacturer Narrative

The device was stated to be available for return to the manufacturer for evaluation but has not yet been returned.The alleged product issue / foreign material 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 Description

It was reported that during preparation, once the guidewire was hydrated, they proceeded to insert it into the microcatheter through the guide pin.They noticed it released tiny dark-colored material.The device was not used.Although there was no patient involvement or contact, it is possible that the foreign material/contamination could potentially go undetected and could cause or contribute to a death or serious patient injury should the event recur.Therefore, the event is being reported.

Event Description

Additional information received notes they normally use headway, neuroslider, echelon microcatheters, although it is unknown which was used during this incident.The preparation process was explained as follows: as usual, they hydrated the traxcess inside the container tube and in the tray, and then, they passed the traxcess through the microcatheter.They noticed some kind of friction between the traxcess and the microcatheter that they were not used to.No other clarification was provided.

Manufacturer Narrative

B5: additional information provided d10: device received h10: investigation: actual sample received: one guidewire; one mandrel.Visual inspection of the guidewire: there was no foreign material adhering to the guidewire.Magnifying inspection of the guidewire: there was no coil disturbance or kink in the platinum coil section and stainless steel coil section.Intermittent peeling of ptfe coat was observed on the following areas of the shaft: approx.1140 mm -approx.1510mmfrom the distal end; approx.1630 mm - approx.1730mmfrom the distal end; approx.1770 mm - approx.1850mmfrom the distal end; there were no scratches or other anomalies on the other part of shaft section.Dimensions of the guidewire: outer diameter of the platinum coil section: it met the factory's specifications.No anomaly was found.Outer diameter of the stainless steel coil section: it met the factory's specifications.No anomaly was found.Outer diameter of the shaft section: it met the factory's specifications.No anomaly was found.Visual inspection of the mandrel: there was foreign substance adhering to the distal end of mandrel.From the description of the event, this was thought to be ¿tiny dark-colored material¿ released from the guidewire.Magnifying inspection of the foreign substance: it was a blue thread-like substance.Component analysis of the foreign substance (ft-ir*) the peak of the foreign substance was similar to the peak of the ptfe coat.Therefore, it was considered that the tiny dark-colored material pointed out in this complaint was a piece of ptfe coat peeled off from the actual sample.*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.Past simulation test: a factory-retained traxcess was once inserted into an attached metal inserter, and then held curved and pulled out in order that the shaft section would be exposed to abrasion load by being in contact with the distal edge of metal inserter.Peeling of ptfe coat occurred in the shaft section.The condition of the test sample was considered to be similar to that of the actual sample.In the manufacturing process, the following operations and inspections are performed to maintain 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.Conclusion: evaluation on the return device showed a blue thread-like substance was found adhering to the distal end of the mandrel.Ftir testing was performed on the substance, and it was found to be most consistent with ptfe coating, which was found to be peeling off of the returned guidewire shaft.Based on the investigation result, no anomaly was found in the manufacturing record, the shipping inspection record, and dimensions of the actual sample.From the condition of the actual sample and the result of the simulation test, as one of the possibilities, it was inferred that the surface of shaft section came into contact with some kind of hard object (such as the tip of a metal inserter) and was exposed to abrasion load, which resulted in the peeling of ptfe coat.

• Brand Name: TRAXCESS 14 GUIDEWIRE
• Type of Device: ACCESS DEVICES, WIRE, GUIDE, CATHETER
• Manufacturer (Section D): MICROVENTION, INC; 35 enterprise; aliso viejo CA 92656
• Manufacturer (Section G): MICROVENTION, INC; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 18193873
• MDR Text Key: 328821826
• Report Number: 2032493-2023-01071
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 00810170012280
• UDI-Public: (01)00810170012280(11)000101(17)260131(10)230228
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080863
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GW1420040
• Device Lot Number: 230228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2000
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1