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

Model Number	N/A
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
Additional Manufacturer Narrative
E3: occupation: ic fellow.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.Since the involved lot number was unknown, review of manufacturing records and the shipping inspection records could not be performed.Since the involved lot number was unknown, past complaint files could not be searched.Regarding the involved product code, there was not any nonconformance in the manufacturing process that could lead to the reported event in the past three years (november 2022 -october 2023).Ashitaka factory strives to maintain the product quality by performing the 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 hydrophilic coating solution and the stirring time are controlled so that the coating amount and condition are managed to be uniform.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 statement: "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." for the importer report please see 2243441-2023-00036.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 on (b)(6) 2023, during a conversation with an interventional cardiology fellow doctor, it was mentioned that two months ago there was a perforation caused by the runthrough guidewire involved.The procedure performed was a percutaneous coronary intervention (pci).
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide additional information to section b5.
Event or Problem Description
Additional information was received on 31oct2023: the doctor recalled that did not utilize a coil as a result of the perforation.
Additional Manufacturer Narrative
This report is being submitted as follow up no.2 to provide an explanation of section d4: udi.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 ; 6402040886
• MDR Report Key: 18048200
• Report Number: 9681834-2023-00196
• Device Sequence Number: 12825632
• 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,Followup
• Report Date (Section B): 11/01/2023

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: N/A
• Device Catalogue Number: 25-1011
• 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: 10/10/2023
• Supplement Date Received by Manufacturer: 10/31/2023; 07/03/2024
• Initial Report FDA Received Date: 11/01/2023
• Supplement Report FDA Received Date: 11/13/2023; 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