MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA NAVICROSS 0.018"; CATHETER, PERCUTANEOUS

Model Number N/A

Device Problems Material Separation (1562); Physical Resistance/Sticking (4012)

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

Event Date 03/19/2021

Event Type  malfunction  

Manufacturer Narrative

Patient identifier - requested, not provided.Age & date of birth - requested, not provided.Patient sex - requested, not provided.Weight - requested, not provided.Ethnicity - requested, not provided.Race - requested, not provided.Implanted date: device was not implanted.Explanted date: device was not explanted.This report has been deemed reportable based upon evaluation of the actual sample.The actual samples were received for evaluation.The actual samples were a navicross (catheter), which had been fractured into three parts, the distal portion, intermediate piece, and hub, and a guidewire advantage (guidewire).The guidewire was in the state of having been combined with the distal portion of the catheter.Inspection of the catheter hub: magnifying inspection found peeled ptfe coat of the guidewire adhering inside the catheter hub.X-ray fluoroscopic inspection found that the catheter shaft had been fractured at the root of the hub.The coil marker was missing from the area between the distal end of the catheter shaft and the fracture end.Inspection of the intermediate piece of the catheter: the total length of the intermediate piece was approximately 283 mm.Each end was referred to as end-a and end-b.The intermediate piece was inspected under a magnifier.End-a had been tapered and end-b had been twisted.The coil marker had been unraveled and exposed from end-b.The intermediate piece was inspected under an electron microscope.End-a seemed to have been stretched and torn, and the fracture surface of end-b was smooth.The intermediate piece was inspected under x-ray fluoroscope.Disconnection of coil marker was revealed at approximately 130 mm, 160 mm, 220 mm, and 230 mm from end-a.The intermediate piece was cut lengthwise to confirm the state of inner wall.Disruption of inner layer was observed in the position where the disconnection of coil marker occurred.Peeled ptfe coat of the guidewire was found adhering near the disconnection part of the coil marker.Inspection of the distal portion of the catheter and the guidewire: visual inspection found that the guidewire was stuck in the distal portion of the catheter and impossible to be removed.The distal end of the guidewire had been fractured.The total length of the guidewire was approximately 2988 mm and the distal portion of the catheter was approximately 1269 mm.The distal portion of the catheter was inspected under a magnifier.The distal end had been deformed.A constriction of tube due to elongation was found at approximately 100 mm from the distal end.The proximal end had been fractured.Electron microscopic inspection of the distal portion of catheter found that the proximal end seemed to have been stretched and broken.X-ray fluoroscopic inspection of the distal portion of the catheter found that the coil marker in the third radiopaque marker located at 100 mm from the distal end had been jumbled and disconnected.No anomalies such as obstruction of the lumen were found in the first and second radiopaque markers and the remaining part.The length of the urethane-coated section of the guidewire was approximately 238 mm.Compared to the same part of a normal product, which was 250 mm, the actual sample was missing 12 mm.Magnifying inspection of the guidewire found a bend near the fracture.The outer layer at the fracture seemed to have been stretched and broken.Peeling of ptfe coat was observed at approximately 275mm, 750mm and 2720mm from the distal end.Electron microscopic inspection of the guidewire found multiple creases and abrasions on the outer layer surface near the fracture.The urethane coat was removed, and then the guidewire was inspected under an electron microscope.The core wire and the coil had been fractured and curved in different directions.The core wire was tapered.The fracture surface of the core wire was rough.Dimensional inspection: the outer and inner diameters of the catheter were measured.Both were within the control criteria.Od: 0.84 mm, id: 0.49 mm.The length between the distal end of the catheter and the root of the hub was 1552 mm.Compared to the same part of a normal product, which was 150 mm, the actual sample had been elongate 52 mm.The outer diameter of the guidewire was measured and confirmed 0.45 mm, which met the control criteria for 0.018" guidewire advantage.A review of the device history record and the shipping inspection record of the involved product code/lot# combination was conducted with no findings.Mechanism of the guidewire fracture: terumo ashitaka factory is aware that the guide wire may get fractured when it has been subjected to one of the loads described below and the fracture section of the core wire presents some regularity depending on the load the guide wire has been subjected to.Pulling load to the test sample kept in a loop shape: the fracture end of the core wire has been curved and the fracture surface is rough.This state is similar to that observed on the actual guidewire sample.Pulling load to the test sample in one direction: the outside diameter of the core wire has been diminished toward the fracture end; however, the distal end had not been curved.The mechanism of occurrence is thought to be different from that of the actual guidewire sample.Repetitive bending load: the fracture end of the cores wire is not flat and dimple pattern is observed on the fracture surface.The mechanism of occurrence is thought to be different from that of the actual guidewire sample.One-way torque load to a test sample kept in a curved shape: the fracture end of core wire is straight and not tapered, and radial pattern is observed on the fracture surface.The mechanism of occurrence is thought to be different from that of the actual guidewire sample.Ifu states: (navicross) carefully handle the product under fluoroscopy.If any resistance is felt while handling the product, immediately stop the manipulation and find out the cause to avoid damage to blood vessels and separation or breakage of the product.(guidewire advantage) if any resistance is felt or if the tip's behavior and/or location seems improper, stop manipulating the glidewire advantage and/or the catheter and determine the cause by fluoroscopy.Continuing to manipulate or rotate the glidewire advantage or failure to exercise proper caution may result in bending, kinking, separation of the guide wire's tip, damage to the catheter, or damage to the vessel.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.It is likely that the ptfe coat of the guidewire was peeled off due to the abrasive load applied to the guidewire as it passed through the lesion.The guidewire with peeled ptfe coat rubbed the inner wall of the catheter, resulting in disruption of the inner layer and coil markers of the catheter.The guidewire was trapped at the third radiopaque marker site, about 100 mm from the catheter tip, due to the disruption of the coil marker.To replace the guidewire, an attempt was made to remove the guidewire however failed because of the trapped state.While the guidewire was left in place, an attempt was made to remove the catheter.As a result, the catheter hub was fractured by tensile and torque loads during removal.Again, tensile load was applied for catheter removal.As a result, the catheter was fractured at approximately 1269 mm from the distal end.Since the coil markers in the intermediate piece of the catheter had been disconnected in several places, it was inferred that the catheter was subjected to intermittent tensile loading.Due to the tensile load during the removal of the catheter removal, stress was concentrated at the point where the guidewire was trapped (about 100 mm from the tip of the catheter), resulting in the elongation of the shaft.When the guidewire and catheter were removed together, the guidewire tip was in the state of having been trapped for some reason, which resulted in the fracture due to tensile load.The reason and timing of the trapping could not be determined.As for the fractured piece of the guidewire, it was not returned, so it might remain in the body.The exact cause of the reported event cannot be definitively determined based on the available information.This report is for the navicross device reported, for the guidewire advantage device reported that was used on the same patient see mdr 9681834-2021-00074.

Event Description

The user facility reported it was a critical limb ischemia case.Access was gained in the left groin for treatment of the right leg.The target lesion started in the sfa and perfuse disease continued throughout the infrapop region.Wire access was obtained using an 018 gwa.The procedure took much time and the equipment was in the body for an extended period of time; the exact time is not known.Successful crossing of the lesion was completed using the gwa and navicross combination.After crossing, and multiple angiograms of the vessels, the physician attempted a wire exchange through the navicross.It was then that the physician had noticeable resistance.He then tried to remove the catheter while leaving the wire in place and was unable to complete the action.It appeared as if the catheter had become fused to the wire.He tried pulling harder and the catheter hub broke free from the rest of the catheter.He then pulled on the catheter again and a second piece broke.At this point he had decided to remove both wire and remaining piece of the fused catheter.There was no patient harm during this event.The case was a success and patient condition was stable.

• Brand Name: NAVICROSS 0.018"
• Type of Device: CATHETER, PERCUTANEOUS
• 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: mary o'neill ; reg. no. 2243441; 950 elkton blvd; elkton, MD 21921 ; 8002837866
• MDR Report Key: 11796622
• MDR Text Key: 261949098
• Report Number: 9681834-2021-00071
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 04987892077319
• UDI-Public: 04987892077319
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173799
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: N/A
• Device Catalogue Number: NC18151
• Device Lot Number: 200717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2020
• 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