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

Model Number N/A

Device Problems Difficult to Insert (1316); Material Deformation (2976)

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

Event Date 03/09/2023

Event Type  malfunction  

Event Description

The user facility reported that the runthorugh ns product was used to treat the peripheral lesion of lcx#13.It was delivered with a zizai, then an attempted to dilate the lesion with 2.0mm a ryurei occurred.However, since the wire came out, it was pushed in together with the balloon.At that time, it turned into a knuckle shape, and the wire did not advance well to the peripheral lesion.Therefore, it was taken out of the patient's body once, confirmed the shaping of distal end, and attempted to change the shape by pulling it a little.However, it could not be changed well and was deformed.Therefore, we decided that it would be difficult to continue the procedure in this state, and it was replaced with a new product to continue the procedure.There was no patient injury/medical or surgical intervention required.The procedure outcome was not reported.The final patient impact was not harmed.No piece of product was remained in the patient's body.

Manufacturer Narrative

Date of birth: requested, not provided.Weight: 68.4 kgs.Ethnicity: requested, not provided.Race: requested, not provided.Udi: n/a as this product code is not exported to the us market.Implanted date: device was not implanted.Explanted date: device was not explanted.Visual inspection of the actual sample found that the distal end had been deformed.Magnifying inspection of the actual sample found that the distal end had been bent, waved and had been kinked (coil pitch had been opened) in multiple sections.The coil had been jumbled at approximately 6mm from the distal end of actual sample.The bend was presumed to be due to shaping.It was also presumed that "deform" described in the reported issue was the waviness, multiple kinks (opening of the coil pitch) and jumbling of the coil.No anomaly such as a bend or kink was found in other sections.Inspection of the platinum coil section of actual sample by hand sensitivity found that it was highly likely that the platinum coil stretched back and forth, and the niti-core wire fractured.To confirm the condition of niti-core wire of the actual sample, the platinum coil was intentionally unraveled, and magnifying inspection of it was performed.The niti-core wire had been fractured at approximately 6mm from the distal end.Electron microscopic inspection of the niti-core wire of actual sample found that the fractured section and fracture surface had been twisted at both the distal side and hand side.Function confirmation was performed.The outer diameter of the platinum coil section (normal section) met the factory's specifications.No anomaly was found.Outer diameter of the stainless-steel coil section met the factory's specifications.No anomaly was found.Bending strength (normal section) met the factory's specifications.No anomaly was found.Outer diameter of the niti-core wire (normal section in the vicinity of fractured section) was equivalent to that of the product with the involved product code.No anomaly was found.The manufacturing record and the shipping inspection record of the product with the involved product code/lot number found no anomaly.Past complaint file of the product with the involved product code/lot number found no other similar report from other facilities.Simulation test: based on our past knowledge, the following simulation tests were performed.A)fracture of the niti-core wire - using factory-retained runthrough ns, the distal end of coil was trapped and following force a) - d) was applied respectively.In each case, it was found that the niti-core wire inside the platinum coil was fractured.Subsequently, electron microscopic inspection of each fractured section of the niti-core wire was performed.The following results were obtained.A)when pulling force was applied, the fractured section was tapered, and dimple patterns (hole-shaped patterns) were found on the fracture surface.These statuses were different from those of the actual sample.B)when repeated bending force was applied, the fractured section was curved, and dimple patterns (hole-shaped patterns) were found on the fracture surface.These statuses were different from those of the actual sample.C)when pulling force was applied in a looped state, the fractured section was curved, and the fracture surface was twisted.These statuses were different from those of the actual sample.D)when torque force was applied, the fractured section and the fracture surface were twisted.These statuses were similar to those of the actual sample.B)jumbling of the coil on the platinum coil section.The distal end of factory retained runthrough ns was trapped, and continuous torque force was applied to the shaft.As a result, the platinum coil section was jumbled.This status was similar to that of the actual sample.The coil and the niti-core wire of this product are fixed at three places, and the coil and the niti-core wire are free except for the fixed sections.The winding direction of the coil section of the involved product is clockwise.When torque force is applied to the clockwise rotation, the winding wire density for a coil becomes high, and when torque force is applied to the counterclockwise rotation, the winding wire density for a coil becomes low.Therefore, if torque force is continuously applied to the clockwise rotation while the coil is trapped, the coil may get over and the coil may be jumbled.Based on the investigation result, as a possible cause of this case, following factor was inferred.The distal end of actual sample was trapped by some factor (e.G.Stenotic lesion).In the condition of "1", continuous torque force was applied to the actual sample, which caused jumbling of coil in the platinum coil section at approximately 6mm from the distal end, and fracture in the niti-core wire inside the coil.After removing the actual sample from the patient's body, an attempt was made to shape the distal end of actual sample.However, since the niti-core wire was fractured, shaping of it could not be performed.Regarding the cause of multiple kinks (opening of the coil pitch) at the distal end of actual sample, it was inferred that when the actual sample was inserted into the lesion, the distal end of actual sample was pushed in with a knuckle shape, and excessive bending force was applied to the involved section.Relevant instructions for use (ifu) reference: "when selecting the vessel in which the runthrough ns is to be inserted or when advancing the guide wire through the stenosis, do not turn the proximal end of the guide wire three or more turns in succession in the same direction if the guide wire's tip is trapped.Separation of the guide wire may result." terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).

• Brand Name: RUNTHROUGH NS
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 6402040886
• MDR Report Key: 16706720
• MDR Text Key: 312946792
• Report Number: 9681834-2023-00079
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K063695
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: TW-GS418VDZ
• Device Lot Number: 221114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2022
• 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
• Treatment: HEARTRAIL II 6FR; RYUREI 2015
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 68 KG