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

Model Number	GW1420040
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record and product release decision control sheet of the involved product/lot number combination were reviewed and no anomaly related to the event was found.The device was returned to the manufacturer for analysis.The investigation is currently underway.A supplemental report will be submitted upon completion of product evaluation.
Event or Problem Description
It was reported that during treatment of an aneurysm on the left ica, a traxcess soft guidewire was chosen for cannulating the aneurysm.The physician observed some kind of material on the surface when the traxcess guidewire was pulled out of the microcatheter.Physician had the impression that the hydrophilic coating sheered off from the guidewire body.The guidewire was exchanged for another traxcess soft and procedure continued with good result.There was no report of harm or injury to the patient, who was doing well.
Additional Manufacturer Narrative
Additional information: h10 (summary device evaluation).Summary device evaluation: based on the results of the investigation, as one of the possibilities in this case, it was presumed that the actual sample was subjected to withdrawal manipulation while its stainless steel coil section and shaft section surfaces were in contact with a hard object (e.G., edge of the metal inserter that came with the product), resulting in the peeling of the hydrophilic coating and outer layer due to the abrading load applied to the area in question.As for the cellophane, it is not used in the manufacturing process of this product.In addition, a lump of cellophane like that adhered on the actual sample is probable to be detected through the 100% visual inspection.Therefore, it is inferred that it was at some point after the actual sample was opened or afterward until the actual use when the cellophane was attached to the actual sample.

• 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: 13862597
• Report Number: 2032493-2022-00105
• Device Sequence Number: 4716912
• Product Code: MOF
• UDI-Device Identifier: 00810170012280
• UDI-Public: (01)00810170012280(11)210412(17)240331(10)210412
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 02/22/2022

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: 03/31/2024
• Device Model Number: GW1420040
• Device Catalogue Number: GW1420040
• Device Lot Number: 210412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2022
• Supplement Date Received by Manufacturer: 02/22/2022
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 04/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/12/2021
• 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 Age: 43 YR
• Patient Sex: Female