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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Perforation (2001)

Event Date 10/26/2022

Event Type  Injury  

Manufacturer Narrative

Implanted date: device was not implanted, explanted date: device was not explanted.The actual device was not available; therefore, the actual device will not be returned for evaluation.Review of the manufacturing record and the shipping inspection record of the involved product code/lot number combination confirmed that there was not any anomaly in them.A search of the complaint file found no other similar report with the involved product code/lot number combination from other facilities.Based on the investigation result, no anomaly related to the involved event was found in the manufacturing record and the shipping inspection record.Moreover, we obtained the additional information that there was no malfunction of the wire.In this case, since the actual sample and cine image were not sent, the cause of occurrence could not be clarified.Ashitaka factory is always continuing diligence in maintaining the product quality by performing following inspections.In the product assembling process, 100% visual inspection is performed to assure that there is no deformation in the coil.After the product assembling process, the outer diameter is measured on 100% basis to assure that there is no anomaly on it.After the product assembling process, the tip abutting resistance is measured on 100% basis to assure that there is no anomaly in the tip load.The dispensing amount of materials and stirring time of the hydrophilic coat solution are controlled to control that the coating amount and coating condition are uniform.In the shipping inspection, the tip abutting resistance is measured for each lot to assure that there is no anomaly in the tip load.In the shipping inspection, the tip sliding resistance value is measured per lot number basis to assure that there is no anomaly in its lubricity.The instructions for use (ifu) has 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., 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.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." please see mdr 2243441-2022-00028 for the importer report.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 Description

The user facility reported a potential coronary perforation, there was no angiographic evidence during the case.The doctor performed a percutaneous coronary intervention (pci) of the mid lad over a izanai 180 cm wire.The patient's blood pressure dropped significantly.After assessing the patient, the doctor believed the bleed to be into the pericardium.A pericardiocentesis was performed to drain the fluid.The patient became stable and was released.The doctor does not deem this to be caused by a defect of the wire.The wire did not separate or malfunction in anyway.The patient was in stable condition.The procedure outcome was a success.The event occurred intra-operative.Pericardiocentesis was required.Additional information was received on 03 nov 2022: there was no angiographic evidence of an incident.The patient coded a few hours after the procedure.A needle was used to drain the fluid out of the pericardium.The physician stated the incident could have only been caused by a wire perforation.A boston science balloon and stent were used.

• Brand Name: RUNTHROUGH NS
• Type of Device: 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: gina digioia ; reg. no. 2243441; 950 elkton blvd; elkton, MD 21921 ; 6402040886
• MDR Report Key: 15853735
• MDR Text Key: 304206438
• Report Number: 9681834-2022-00233
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 34987350734700
• UDI-Public: 34987350734700
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063695
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 25-5211
• Device Lot Number: 220829
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BOSTON SCI BALLOON; RUN THROUGH IZANAI; STENT
• Patient Outcome(s): Required Intervention; Other
• Patient Sex: Female