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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Review of the manufacturing record and the shipping inspection record.No anomaly was found.Search of the complaint file.No other similar report from other facilities was found.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.
Event or Problem Description
The user facility reported that the device involved was being used to cross over severely diseased circumflex artery.The guidewire tip suddenly broke off from the shaft.The patient was not injured, medical or surgical intervention was not required.Patient condition was stable.The procedure outcome was a success.The event occurred intra-operative.
Additional Manufacturer Narrative
Since the actual sample was not returned, investigation of it could not be performed.Record review results and udi no were reported in the preliminary answer card.Simulation test was based on our past knowledge, we have been aware that the guidewire fractures when the following force a-d was applied.We have also been aware that there is regularity in the shape of fractured section of the core depending on the mechanism leading to the fracture.A) when pulling force is applied: fracture surface: dimple patterns fractured section: tapering, and diagonal fracture surface b) when repeated 90° bending force is applied: fracture surface: dimple patterns fractured section: curve c) when pulling force is applied to a looped guidewire: fracture surface: twist fractured section: curve and tapering d) when torque force is applied: fracture surface: twist fractured section: twist under the conditions of a-d where the core wire had been fractured, when the test sample was pulled in the removal direction, the platinum coil was unraveled and elongated in any of the cases.We have been aware that the platinum coil becomes fractured when removal force is applied further.Based on the investigation result, as a possible cause of this complaint, the following factor was inferred.However, since the actual sample was not returned, the cause of occurrence could not be clarified.The distal coiled section of the actual sample was trapped due to some factor (e.G., stenosis lesion).The actual sample in the state described was exposed to one of the force a-d, which resulted in the fracture of niti core wire inside the platinum coil.Subsequently, removal operation was performed.As a result, the platinum coil was unraveled and elongated.As the removal operation was continued, the platinum coil was fractured.In order to clarify the cause of occurrence, we would like to ask for your cooperation in obtaining the actual sample in the future.Ashitaka factory is always making efforts to maintain the product quality by performing following control.After the coil/niti-core wire fixing process, 100% visual inspection is performed to assure that there is no deformation on the coil.After the product assembling process, the outer diameter is measured on 100% basis so that it is assured that there is no anomaly on it.100% pulling strength test is performed in the manufacturing process to confirm that there is no anomaly in the strength.In the shipping inspection, pulling strength is measured on sampling basis per product code/lot to confirm that there is no anomaly in the strength.Please keep in mind the following warning in instructions for use (ifu) when using this product in the future.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 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.
Additional Manufacturer Narrative
This report is being sent as follow-up no.2 to correct section d3.

• Brand Name: RUNTHROUGH NS
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, MD 418 ; JA 418
• 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: 17375364
• Report Number: 9681834-2023-00144
• Device Sequence Number: 3784701
• Product Code: DQX
• UDI-Device Identifier: 04987350703583
• UDI-Public: 04987350703583
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/21/2023

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: 10/31/2025
• Device Model Number: N/A
• Device Catalogue Number: 25-1013
• Device Lot Number: 221121A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2023
• Supplement Date Received by Manufacturer: 09/14/2023; 12/15/2024
• Initial Report FDA Received Date: 07/22/2023
• Supplement Report FDA Received Date: 10/14/2023; 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2022
• 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: Other
• Patient Sex: Unknown