MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA RUNTHROUGH NS; WIRE, GUIDE, CATHETER

Model Number TW*AS418XA

Device Problem Material Deformation (2976)

Patient Problem No Information (3190)

Event Date 10/22/2018

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.The actual sample was received for evaluation.Visual inspection revealed that the stainless steel section had been deformed into a spiral shape in total length, from approximately 30 - 250 mm from the distal end of the device.Magnifying inspection of the platinum coil section found that it had been kinked at approximately 1 mm and 5 mm from the distal end of the device.On approximately 28 - 30 mm from the distal end of the device, the coil had been stretched (the coil pitch had been widened).Magnifying inspection of the deformed stainless steel coil section confirmed that the coil pitch had not been widened.The outside diameters of the undamaged platinum coil section and of the platinum coil section were confirmed to meet manufacturer specifications.Reproductive testing was performed using a factory retained ptca guide wire, a factor-retained ivus catheter and a factory-retained guiding catheter (6fr.) the ivus catheter was advanced over the ptca guide wire through the guiding catheter placed in the phantom vessel into the bifurcated branch.The distal section of the ptca guide wire placed in the bifurcated branch was clamped with forceps to simulate it being trapped in a calcified lesion.With the ivus catheter being fixed, pushing force was applied to the ptca guide wire.The coiled section of the ptca guide wire got bent into a loop-like shape and entered the main trunk.With the proximal section of the ptca guide wire being fixed, the ivus catheter was withdrawn.Some resistance was felt at the bifurcation.Under the resistance, the ivus catheter was further pulled.This led the trapped distal section of the ptca guide wire to be released and the ptca guide wire was moved in the proximal direction together with the ivus catheter with the coiled section being bent into a loop-like shape.During further withdrawal of the ivus catheter, the loop-like deformed section of the ptca guide wire was caught in the guidewire port of the ivus catheter at the distal end of the guiding catheter.Further withdrawal of the ivus catheter under resistance resulted in the ptca guide wire being pulled into the guiding catheter together with the ivus catheter with the loop-like shape kept on it.The ivus catheter and the ptca guide wire were withdrawn from the guiding catheter and the ptca guide wire was separated from the ivus catheter.The ptca guide wire was found to have been bent into a spiral shape on the stainless steel coil section on approximately 170 -250 mm from the distal end of the device.Damage which was similar to that on the stainless steel coil section on the actual sample was duplicated.The coiled section of the ptca guide wire was subjected to compressive force and bent into the spiral shape.In this test, the platinum coil section did not get stretched/the coil pitch did not widen.Review of the device history record and shipping inspection record of the involved product code/lot# combination was conducted with no findings.Ifu states: if any resistance to the runthrough ns or the dilatation catheter is felt during manipulation or if the shape, behavior or position of the guide wire's tip seems improper, e.G., in a case where the tip is trapped due to vessel spasm or some other cause or the tip is folded as shown in fig.2, stop manipulating the guide wire (and the catheter) and determine the cause carefully by fluoroscopy and take suitable remedial actions.Then remove the guide wire slowly, without turning, to exchange it for a new one.Continuing guide wire or catheter manipulation in the said situations may result in damage to the vessel, damage to or separation of the guide wire's tip, and/or damage to the dilatation catheter.There is no evidence that this event was related to a device defect or malfunction.Based on the investigation results, it is likely that when the actual sample was inserted into the bifurcated branch, the coiled distal section was trapped by a hard object, including a calcified section of the lesion.To get released from the trap, the actual sample was subjected to excessive pulling force, when the platinum coil was elongated on approximately 28-30 mm from the distal end of the device.After the involved ivus catheter was inserted into the bifurcated branch, the actual sample was subjected to pulling and pushing force and entered the main trunk, forming a loop-like shape.When an attempt was made to withdraw the involved ivus catheter with the proximal end of the actual sample being fixed, the loop-shaped coil section of the actual sample was being caught in the bifurcation.Under some resistance further withdrawal of the involved ivus catheter released the trap of the actual sample.The actual sample was started to move into the guiding catheter together with the involved ivus catheter with the loop-like deformity kept on the coiled section.The involved ivus catheter was withdrawn from the guiding catheter.And when the actual sample was withdrawn from the involved ivus catheter, the stainless steel coil section of the actual sample was deformed into a spiral shape on approximately 30 - 250 mm from the distal end of the device.However, the exact cause of the reported event cannot be definitively determined based on the available information.This report is for the first device reported.For the second device reported, that was used on the same patient, see mdr 9681834-2018-00215.(b)(4).

Event Description

The user facility reported the runthrough wire became stuck on the ivus (intravascular ultrasound) catheter and would not come out during lhc (left heart cath).The physician had to pull fairly hard, and pulled back on both the runthrough and ivus catheter and the ikari left 3.75 guide he was using, as he was concerned that the wire had separated.Once he got it out, he inspected it, and nothing was left behind.However, the wire had started to separate and was completely coiled up/corkscrew up.Initially the wire and ivus catheter went down the circumflex fine, it was upon pull back that the wire and catheter became stuck together.The doctor said severely calcified and 90 degree turn so the calcium and angle probably forced the wire to kink and the ivus to become stuck on the wire.After pulling it all out, doctor ballooned and stented, and then tried to ivus again.However, the same thing happened for a second time.This time he did not force it when he felt resistance and pulled everything out.The second runthrough was kinked.He was able to complete case; the left heart catheterization was successful.The patient was reported to be stable and fine.User facility medwatch report # (b)(4) was received by terumo medical on november 28, 2018 and reported: "during ivus of circumflex artery for pci, the acist ivus catheter was stuck on a runthrough coronary guidewire during attempted removal.To troubleshoot, the wire and the ivus catheter were carefully pulled back into the guidecatheter.The ivus catheter was then able to be removed off the wire and noted to be torn at the monorail exit point where the coronary wire would exit.The runthrough wire was then noted to be stuck within the guidecatheter.Thus a snare device was used to successfully retrieve and remove the runthrough wire.All segments of the wire were confirmed to be removed out of the body, and confirmed by comparing to a brand new wire outside of the body.Brand new coronary wires used to complete the intervention.Post-stent deployment, a brand new ivus catheter was used to perform post pci ivus catheter were immediately removed as a unit successfully.No foreign body remained in the patient.No harm done to patient.Original intended procedure cardiac catheterization".

• Brand Name: RUNTHROUGH NS
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer Contact: mark vornheder ; reg. no. 2243441; 950 elkton blvd; elkton, MD 21921 ; 8002837866
• MDR Report Key: 8183849
• MDR Text Key: 131899223
• Report Number: 9681834-2018-00214
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 04987350779373
• UDI-Public: 04987350779373
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063695
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: TW*AS418XA
• Device Catalogue Number: 25-1011
• Device Lot Number: 180703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2018
• Initial Date FDA Received: 12/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2018
• 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
• Patient Age: 48 YR