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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that during a cardiac catheterization interventional cardiology procedure, the tip of the involved runthrough ns broke off and was left behind in the patient's coronary artery.No further intervention was performed, and the patient was stable.No blood loss was reported.There is not a direct allegation that the reported device caused or contributed to patient injury and/or need for medical intervention.Additional information was received on 29 feb 2024: other devices used included three (3) different pca balloons (2.0x15, 1.0x10, 2.0x8nc) tig catheter, ebu catheter, wire extension, turnpike catheter, and 2.25x18 drug eluding stent.
Additional Manufacturer Narrative
A5: ethnicity: not provided for animal use.A6: race: not provided for animal use.D4: lot number: requested, unknown.D4: expiration date: unknown due to unknown lot number.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.H4: device manufacture date: unknown due to unknown lot number.Since the actual sample was not returned, investigation of it could not be performed.Since the lot number was unknown, history investigation of the product with the involved product code/lot number could not be performed.In the past three years for the product with the involved product code, we have not received any events caused by the manufacturing process.Based on our past knowledge, we have been aware that the guidewire was fractured when the following force a) - d) was applied.We have also been aware that there was regularity in the shape of fractured section on the wire depending on the mechanism leading to the fracture.A) when pulling force was applied.Fractured surface: dimple pattern was found.Fractured section: it was tapered, and the fractured surface was slanted.B) when repeated 90° bending force was applied.Fractured surface: dimple pattern was found.Fractured section: it was curved.C) when pulling force was applied in a looped state.Fractured surface: it was twisted.Fractured section: it was curved and tapered.D) when torque force was applied.Fractured surface: it was twisted.Fractured section: it was twisted.When the removal operation is performed under each condition of a) - d), the platinum coil is unraveled and elongated.We have been aware that when removal force was further applied continuously, the platinum coil fractures.Based on the investigation result, since the actual sample was not returned, it was not possible to clarify the cause of occurrence.Ashitaka factory is always making efforts to maintain the product quality by performing following controls.After the product assembling process, 100% visual inspection is performed to confirm that the coil is not deformed.After the product assembling process, the outer diameter is measured on 100% basis to confirm that there is no anomaly on it.In the shipping inspection, pulling strength is measured on sampling basis per product code/lot to confirm that there is no anomaly in strength.Instruction for use (ifu) of this product includes the following warning: "if any resistance to the runthrough ns or the dilatation catheter is felt during manipulation or if the shape, behaviour 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." terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.
Additional Manufacturer Narrative
Visual and magnifying inspections: the distal end had been fractured, and was missing, including the coil.The length of niti-core wire was approximately 23mm.Since the length of platinum coil section is 30mm, it was inferred that the missing length was approximately 7mm.No anomaly was found in other sections.Electron microscopic inspection: the fractured section of niti-core wire had been tapered.The fractured surface was slanted.Dimple patterns (hole-shaped patterns) were found on the fractured surface.Confirmation of the outer diameter of stainless-steel coil section the factory's specifications.No anomaly was found.Simulation test: based on our past knowledge, we have been aware that the guidewire was fractured when the following force a) - d) was applied.We have also been aware that there was regularity in the shape of fractured section on the wire depending on the mechanism leading to the fracture.A) when pulling force was applied.· fractured surface: dimple pattern was found.· fractured section: it was tapered, and the fractured surface was slanted.B) when repeated 90° bending force was applied.· fractured surface: dimple pattern was found.· fractured section: it was curved.C) when pulling force was applied in a looped state.· fractured surface: it was twisted.· fractured section: it was curved and tapered.D) when torque force was applied.· fractured surface: it was twisted.· fractured section: it was twisted.When the removal operation is performed under each condition of a) - d), the platinum coil is unraveled and elongated.We have been aware that when removal force was further applied continuously, the platinum coil fractures.Based on the investigation result, as a possible cause of this case, following factor was inferred.However, since the details of procedure were unknown, it was not possible to clarify the cause of occurrence.The distal end of actual coil was trapped for some reason.In that condition, pulling force was applied to the involved section, causing the niti-core wire inside the platinum coil to fracture.Subsequently, removal operation was performed.As a result, the platinum coil was elongated and fractured.Ashitaka factory is always making efforts to maintain the product quality by performing following controls.After the product assembling process, 100% visual inspection is performed to confirm that the coil is not deformed.After the product assembling process, the outer diameter is measured on 100% basis to confirm that there is no anomaly on it.In the shipping inspection, pulling strength is measured on sampling basis per product code/lot to confirm that there is no anomaly in strength.Instructions for use (ifu) of this product includes the following warning: "if any resistance to the runthrough ns or the dilatation catheter is felt during manipulation or if the shape, behaviour 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.".

• Brand Name: RUNTHROUGH NS
• Common Device Name: 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 ; 4103927218
• MDR Report Key: 18923692
• Report Number: 9681834-2024-00036
• Device Sequence Number: 6189099
• Product Code: DQX
• UDI-Device Identifier: 04987350779373
• UDI-Public: 04987350779373
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2024

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 Model Number: N/A
• Device Catalogue Number: 25-1011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2024
• Supplement Date Received by Manufacturer: 04/09/2024
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 2.25X18 DRUG ELUDING STENT; EBU CATHETER; PCA BALLOONS (2.0X15, 1.0X10, 2.0X8NC); TIS CATHETER; TURNPIKE CATHETER; WIRE EXTENSION
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown