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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record and product release decision control sheet of the involved product/lot# combination were reviewed and no anomaly related to the event was found.The device has not yet been returned to the manufacturer for analysis.
Event or Problem Description
It was reported that during device preparation, the coating appeared to be coming off the guide wire.The device was not used in the patient.
Additional Manufacturer Narrative
The device has been returned to the manufacturing site for evaluation.The investigation is currently underway.
Additional Manufacturer Narrative
An investigation of the returned device found the outer layer to have been scraped off with an exposed core wire.An attempt was made to insert a factory-retained traxcess into a metal inserter attached to the product, and then, with the shaft of the traxcess being in contact with the distal edge of the inserter, withdraw the traxcess in a curved direction.As a result, the outer layer was peeled off in the longitudinal direction in a manner that was similar to that observed in the actual sample.Based on the investigation results, it was presumed that the actual sample was exposed to an abrading load while its shaft section surface was in contact with the distal edge of a metal inserter, which resulted in the peeling of outer layer.When withdrawing this product from the attached metal inserter, it must be withdrawn in a straight line from the inserter without bending it.

• 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
• MDR Report Key: 10840774
• Report Number: 2032493-2020-00328
• Device Sequence Number: 2909126
• Product Code: MOF
• UDI-Device Identifier: 00810170012280
• UDI-Public: (01)00810170012280(11)200623(17)230531(10)200623
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/07/2021

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: Other
• Device Expiration Date: 05/31/2023
• Device Model Number: GW1420040
• Device Catalogue Number: GW1420040
• Device Lot Number: 200623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Initial Date Received by Manufacturer: 10/14/2020
• Supplement Date Received by Manufacturer: 12/11/2020; 01/14/2021
• Initial Report FDA Received Date: 11/13/2020
• Supplement Report FDA Received Date: 01/09/2021; 02/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1