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

Model Number	25-1013
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E3: occupation: risk manager.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.1.History investigation of the involved product code and lot number.- no anomaly was found in the manufacturing record and the shipping inspection record.- no other similar report from other facilities was found.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).
Event or Problem Description
The user facility reported that a 7x150mm smart vascular stent (c07150ml lot 18328912) was deployed over a terumo runthrough 0.014" wire (manufacturer code 25-1013, lot 240201y) in the left distal superficial femoral artery (sfa).During deployment, the distal end of the wire became trapped behind the stent.In attempting to remove the wire from the stent, there was damage to the distal edge of the smart stent.Multiple attempts were made to disengage the wire and remove it.Attempts were also made to re-cross and balloon the distal edge of the stent, which resulted in further damage to the stent.The patient was ultimately transferred to an acute care hospital for vascular surgery.The access sites were: right common femoral artery; left anterior tibial artery.Sheaths used: rfa: 6f 45cm terumo destination sheath left anterior tibial artery: 6f cordis rain sheath other wires used during the procedure: cordis aquatrack ((b)(6)) terumo glidewire advantage.035" terumo glidewire advantage.014".Lesion information: total occlusion of left superficial femoral artery from ostial to popliteal.Previously treated.Patient discontinued medications.Moderate calcification lesion treated with auryon laser atherectomy and percutaneous transluminal angioplasty (pta) prior to stent placement.Additional information was received on 14nov2024: the patient was stable when they left their obl and the patient was doing fine post procedure.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to update section d9 and to provide the completed investigation results.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.1.History investigation of the involved product code and lot number no anomaly was found in the manufacturing record and the shipping inspection record.No similar report was found in the past complaint file.2.Udi no.(b)(4).Based on the investigation result, no anomaly was found in the manufacturing record and the shipping inspection record.However, since the actual sample was not returned and investigation of it could not be performed, it was not possible to identify the cause of occurrence.Ashitaka factory is committed to maintaining the quality of the product through the following work and inspections.After the product assembling process, 100% visual inspection is performed to confirm that there are no deformations such as kinks or disturbance of coils.After the product assembling process, the outer diameter of the coiled section is measured on 100% basis to confirm that there is no anomaly in it.As a shipping inspection, the tip sliding resistance value is measured per lot number basis to confirm that there is no anomaly in its slidability.Relevant ifu reference: "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., 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), determine the cause carefully by fluoroscopy and take suitable remedial actions (see fig.2).Next, remove the guide wire slowly, without turning, and 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.

• Brand Name: RUNTHROUGH NS
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomya city, 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: stephanie handy ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 9499890491
• MDR Report Key: 20793899
• Report Number: 9681834-2024-00216
• Device Sequence Number: 18116483
• Product Code: DQX
• UDI-Device Identifier: 04987350703583
• UDI-Public: (01)04987350703583(17)270131(10)240201
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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
• Report Date (Section B): 11/27/2024

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: 25-1013
• Device Catalogue Number: 25-1013
• Device Lot Number: 240201Y
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2024
• Supplement Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2024
• 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: 6FR 45CM TERUMO DESTINATION SHEATH.; 6FR CORDIS RAIN SHEATH.; 7 X 150MM SMART VASCULAR STENT.; CORDIS AQUATRACK (C3526SSA).; TERUMO GLIDEWIRE ADVANTAGE .014".; TERUMO GLIDEWIRE ADVANTAGE .035".
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 83 KG