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
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.

• Brand Name: RUNTHROUGH NS
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 20794073
• Report Number: 2243441-2024-00038
• Device Sequence Number: 18090546
• 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
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/27/2024
• Report Date (Section F): 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?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/30/2024
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/31/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/27/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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 ((B)(6)); 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
• Date Report Sent to FDA: 11/27/2024