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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implanted date: device was not implanted, explanted date: device was not explanted.The actual device has not been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.A review of the manufacturing record and the product release decision control sheet of the involved product code/ lot # combination confirmed that there were not any indications of anomaly in them.A search of the complaint file found no other similar reports with the involved product code/lot number combination from other facilities.Please see mdr 2243441-2021-00059 for the importer report.(b)(4).
Event or Problem Description
The user facility reported that they had a st-elevated myocardial infraction (stemi) patient that had a balloon/ stent in the right coronary artery (rca).Upon pulling the rtns out the radiopaque tip was dislodged and had to be snared out.There were no patient complications or issues reported.The procedure was successful.Additional information was received on 26-oct-2021.Contrast was ran post snare to confirm there were no particles left in the patient.There was calcification and tortuosity present, they had to balloon and stent.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide additional information in section b5, to provide a correction to section d4 as the initial product code was confirmed to have been reported incorrectly.To provide the device return date in section d9, update section h3, and to provide the completed investigation results.The actual sample was received by ashitaka factory on november 29, 2021.The actual sample upon receipt was one runthrough ns.Visual inspection of the actual sample found that the distal end of platinum coil section had been fractured, and the coil had been frayed and fractured.The fractured piece on the distal side of platinum coil section had been held with forceps.Magnifying inspection of the fractured piece on the distal side of platinum coil section obtained following results.Since the fractured section of niti core wire was covered with the platinum coil, the platinum coil was elongated, and the state of fractured section was confirmed.Since the platinum coil section was held with forceps, it was crushed.The platinum coil and the niti core wire inside the platinum coil were fractured.The niti core wire length inside the platinum coil of actual sample was measured and was compared with a factory-retained current product.No missing was found.Since the platinum coil was frayed and elongated, the platinum coil length could not be measured.Niti core wire length inside platinum coil.Actual sample: approx.30mm (distal side: approx.7mm, rear end side: approx.23mm).Current product: approx.30mm.Electron microscopic inspection of the fractured section of niti core wire found that the fractured section had been twisted and a dimple pattern (a hole-shaped pattern) had been appeared on the fractured surface.The thickness of niti core wire in the vicinity of fractured section was measured.It was equivalent to the current product, and no anomaly was found.Based on our past knowledge, the following simulation test was performed.Using a factory retained runthrough ns, the distal end of coil was trapped and following force were applied respectively.In each case, the niti core wire inside the platinum coil was fractured.Then, a removal operation was performed.The platinum coil was frayed and elongated.When the removal operation was continued, it was found that the platinum coil was fractured.Subsequently, electron microscopic inspection of the fractured section of niti core wire was performed.Following results were obtained.When torque force was applied, the fractured section was twisted, and a dimple pattern (a hole-shaped pattern) was found on the fractured surface.It was very similar to the state of actual sample.When pulling force was applied, it was found that the fractured section was tapered, and the fractured surface was inclined.A dimple pattern (a hole-shaped pattern) was found on the fractured surface.It was different from the actual sample.When repeated bending force was applied, the fractured section was curved, and a dimple pattern (a hole-shaped pattern) was found on the fractured surface.It was different from the actual sample.When pulling force is applied in a looped state, the fractured section was curved, and the fractured surface was twisted.It was different from the actual sample.An error was found in the product code that was initially reported via additional information.Therefore, an investigation manufacturing record and the shipping inspection record of the involved product code/lot# combination confirmed that there were not any problems in them.A search of the complaint file found no other similar report with the involved product code/lot# combination from other facilities.The initial product code reported was 25-1013, however the account confirmed the correct product code should have been 25-1011.Based on the investigation result, as a possible cause of this complaint, the following mechanism was inferred caused fracturing.The distal end of actual sample was trapped for some reason (e.G.Calcified lesion).Torque force was applied in the state of "1", and the niti core wire inside the platinum coil of actual sample was fractured.After that, when the removal operation was performed, the platinum coil was frayed and elongated.As a result of continuing the removal operation in the state of "2", the platinum coil of actual sample was fractured.However, the exact cause of the reported event cannot be definitively determined.
Event or Problem Description
Additional information was received on 07december2021.The lesion had calcification and tortuosity when the actual device was used in the lesion.The device was being used alone when the event occurred.

• Brand Name: RUNTHROUGH NS
• Common Device Name: 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: mary o'neill ; reg. no. 2243441; 950 elkton blvd; elkton, MD 21921 ; 8002837866
• MDR Report Key: 12812128
• Report Number: 9681834-2021-00206
• Device Sequence Number: 5548188
• Product Code: DQX
• UDI-Device Identifier: 04987350703583
• UDI-Public: 04987350703583
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K063695
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 25-1011
• Device Lot Number: 210407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2021
• Supplement Date Received by Manufacturer: 11/29/2021
• Initial Report FDA Received Date: 11/15/2021
• Supplement Report FDA Received Date: 12/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown