MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA VISIGLIDE GUIDEWIRE; WIRE, GUIDE, CATHETER

Model Number OL-XA35455M

Device Problems Fracture (1260); Component Missing (2306)

Patient Problem Insufficient Information (4580)

Event Date 08/26/2022

Event Type  malfunction  

Event Description

The user facility reported that during the procedure, it was discovered that the doctor opened an angle package visiglide; however, it was straight.The distal tip was missing, it is not believed to have fallen in the patient.The doctor noticed the issue while the unit was being inserted into the scope.

Manufacturer Narrative

Lot number: requested, unknown.Expiration date: unknown due to unknown lot number.Udi: unknown due to unknown lot number.Implanted date - device not implanted.Explanted date - device not explanted.Initial reporter name: unknown.Health professional: unknown.Occupation: unknown.Device manufacture date: unknown due to unknown lot number.Since the lot number was unknown, the manufacturing history record and the shipping inspection record could not be investigated.Since the lot number was unknown, the complaint file could not be investigated.Based on the investigation result, as one of the possibilities of this case, it was inferred that the guidewire was taken out from the holder tube while the wire clip was not removed.Due to this, excessive load was applied to the relevant part, which resulted in the breakage.Since the actual sample was not returned, the cause of occurrence of this case could not be clarified.In the manufacturing process, we strive to maintain quality by performing the following inspections and control.The core wire used in this product goes through the eddy current flaw detection* inspection at the supplier so that its integrity is assured.In the manufacturing process, the strength of the core wire is assured by controlling the outer diameter.In the product assembling process, 100% visual inspection is performed so that it is assured that there is no kink or bend in the appearance.Before packaging, 100% visual inspection is performed to assure that there is no flaw.As a shipping inspection, the tensile strength of the distal end is determined by sampling for each lot.(*eddy current flaw detection: when an alternating current is passed through a coil, a magnetic field is generated in the direction perpendicular to the current.Eddy currents are generated on the surface of the conductor when the coil is brought close to the conductor (strand wire).If there is a crack in the conductor, the eddy current will avoid the crack and flow in a detour, so the flow will change compared to when there is no crack.Eddy current flaw detection is a method of detecting cracks by detecting changes in eddy current flow.) (b)(4).

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide a correction to section g4.This device is exempt from the 510k; therefore, section g4 should have been left blank.

• Brand Name: VISIGLIDE GUIDEWIRE
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: gina digioia ; reg. no. 2243441; 950 elkton blvd; elkton, MD 21921 ; 6402040886
• MDR Report Key: 15438396
• MDR Text Key: 300440695
• Report Number: 9681834-2022-00192
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 04953170358265
• UDI-Public: 04953170358265
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091417
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OL-XA35455M
• Device Catalogue Number: G-260-3545A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1