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

Model Number TW*DS418FH

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/05/2018

Event Type  Injury  

Manufacturer Narrative

Patient identifier - requested, not provided.Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device was not returned for evaluation.Therefore, the investigation was based upon evaluation of user facility information and retention sample of the involved product code/lot number combination.Visual inspection found no obvious anomaly, such as a kink or fracture, in the appearance along the total length.Magnifying inspection of the platinum coil segment (0mm-30mm from the distal end) revealed no any anomaly, such as a deformity or jumbling of the coil.Magnifying inspection of the stainless steel coil segment revealed no any anomaly, such as a deformity or jumbling of the coil.The outside diameter on the coiled segment was measured and confirmed to meet manufacturer specifications.Magnifying inspection of the uncoiled ptfe coated segment revealed no anomaly.The ptfe coating was confirmed to be intact.A review of the device history record and the shipping inspection record of the involved product code/lot# combination was conducted with no findings.The result of the distal tip fracture strength test conducted on the involved product code/lot# combination during the shipping inspection was closely reviewed.It was confirmed that there was no deviation in the test result.The investigation results verified that the retention sample was the normal product.Based on the investigation result, it is likely that the distal segment of the involved coil was caught in between the vessel wall and the implanted stent strut.Subsequently, in attempts to release the coil, the customer applied excessive force, including pulling force and/or torque force, to the actual sample.This resulted in the reported fracture of the actual sample.However, with no device return the exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).

Event Description

Terumo medical received "an" user facility medwatch report # (b)(4) on december 10, 2018.The event description states the following: the user facility reported that the patient underwent an emergent left heart catheterization coronary angiography with a percutaneous coronary intervention.During the placement of the stent in the om2 vessel the tip of the guide wire became stuck underneath the stent and broke off.The tip of the guidewire was reported to be caught between the stent and the coronary wall.Additional information was received on 12/19/18: the tip of the guidewire still remains in the patient.The patient is in stable condition.A stent placement was used with the wire.Blood loss was less than 250cc.

Manufacturer Narrative

The actual sample was received for evaluation.Visual inspection revealed that the niti core wire and the platinum coil had been fractured at the end of the device.The length from the distal fracture of the niti core wire to the joint of the platinum coil, stainless steel coil and niti core wire was found to be approximately 20mm.That of the factory-retained sample of the same product is approximately 30mm in length.It was found a distal section approximately 10mm in length was missing from the main body.Magnifying inspection of the platinum coil segment located proximal to the fracture end found that the platinum coil had been raveled on the segment 0mm - the joint of the platinum coil, stainless steel coil and the niti core wire.Due to the reveling, the length of the missing portion of the platinum coil was unknown.Magnifying inspection of the stainless steel coil segment confirmed that the coil did not have any anomaly in the appearance.Electron microscopic inspection of the fracture of the niti core wire revealed that the core wire had become diminished toward the fracture end with the fracture cross-section being in the slant shape.Electron microscopic inspection of the fracture cross-section of the niti core wire revealed that the dimple pattern had been generated on the surface.The thickness of the niti core wire was measured on the segment adjacent to the fracture.It was confirmed to be equivalent to that of the factory-retained sample of the same product code.The actual sample: approximately 0.035mm; factory-retained sample: approximately 0.035 mm (measured at approximately 3mm from the distal end of the device), the outer diameter of the stainless steel coil segment was confirmed to meet manufacturer specifications.Reproductive testing of the fracture of the niti core wire was performed on two current samples from the involved product code.With their distal coils being trapped, the samples were subjected to the force as follows respectively until their niti core wires became fractured.Pulling force after application of torque force: the fracture end became diminished and diagonal with the generation of the dimple pattern on the fracture cross-section.This state is found to be similar to that of the fracture on the niti core wire of the actual sample.Repetitive 90-degree bending force: the fracture end did not become diminished or diagonal.This state is found to be different from that of the fracture on the niti core wire of the actual sample.Looping force + pulling force: the fracture end became diminished and deformed into a curved shape with distortion on the fracture cross-section.This state is found to be different from that of the fracture on the niti core wire of the actual sample.Continuous torque force: the core wire became distorted at the facture.This state was found to be different from that of the fractures on the niti core wire of the actual sample.Ifu states: manipulate the runthrough ns carefully when crossing it through a deployed stent.Stent migration, stent deformation, or breakage or separation of the runthrough ns may be caused if the runthrough ns is caught by the deployed stent.There is no evidence that this event was related to a device defect or malfunction.Based on the investigation results, it is likely that the distal segment of the platinum coil of the actual sample was trapped between the stent strut and the blood vessel wall.In attempts to release the trap, excessive pulling force was applied to the actual sample.This fractured the niti core wire located inside the platinum coil.However, the exact cause of the reported event cannot be definitively determined based on the available information.

• 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
• MDR Report Key: 8202522
• MDR Text Key: 131598510
• Report Number: 9681834-2018-00236
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 04987350720986
• UDI-Public: 04987350720986
• Combination Product (y/n): N
• PMA/PMN Number: K063695
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 12/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: TW*DS418FH
• Device Catalogue Number: 25-3011
• Device Lot Number: 180730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2019
• Date Manufacturer Received: 02/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STENT; STENT
• Patient Outcome(s): Other
• Patient Age: 40 YR
• Patient Weight: 111