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

Model Number	25-1011
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the interventional cardiologist experienced wire perforation during a coronary procedure.Additional information was received on (b)(6) 2023: the procedure performed was a circumflex percutaneous coronary intervention (pci).The doctor reported that while shaping the wire, he heard and felt a click during shaping of the wire tip.
Additional Manufacturer Narrative
A1: patient identifier: requested, not provided.A2: age & date of birth: requested, not provided.A3: patient sex: requested, not provided.A4: weight: requested, not provided.A5: ethnicity: requested, not provided.A6: race: requested, not provided.B3: date of event: requested, not provided.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.E3: occupation: clinical manager.H4: device manufacture date: unknown due to unknown lot number.Since the actual sample was not returned, detailed investigation could not be performed, and the cause of occurrence could not be clarified.The manufacturing record and the shipping inspection record of the product with the involved product code/lot number could not be performed since the lot number were unknown.History investigation of the product with the involved product code/lot number could not be performed since the lot number were unknown.In the past three years (as of (b)(6) 2023) for the product with the involved product code, there have been no events caused by the manufacturing process.Ashitaka factory has been making efforts in maintaining the quality of the product by performing following inspections.In the product assembling process, 100% visual inspection is performed to confirm that there is no deformation in the coil.After the product assembling process, the outer diameter is measured on 100% basis to confirm that there is no anomaly on it.After the product assembling process, the tip abutting resistance is measured on 100% basis to confirm 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 sliding resistance is measured for each lot to confirm that there is no anomaly in its lubricity.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., 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." this report is for the second device reported, for the first device reported that was used on the same patient see mdr 9681834-2023-00236.For the importer report please see 2243441-2023-00038.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
This report is being submitted as follow up no.1 to provide a correction to section d4: model number and catalog number.The production lot number was not provided by the user facility; therefore, the entire udi could not be provided.

• 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 ; 950 elkton blvd; elkton, MD 21921 ; 4103927218
• MDR Report Key: 18190904
• Report Number: 9681834-2023-00237
• Device Sequence Number: 6646817
• Product Code: DQX
• UDI-Device Identifier: 04987350779373
• UDI-Public: 04987350779373
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2023

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 Model Number: 25-1011
• Device Catalogue Number: TW*AS418XA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2023
• Supplement Date Received by Manufacturer: 07/03/2024
• Initial Report FDA Received Date: 11/22/2023
• Supplement Report FDA Received Date: 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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