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

Model Number	25-5211
Medical Device Problem Codes	Material Separation (1562); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.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.No other similar report was found in the past complaint file.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.For the importer report for this reported event please see mdr 2243441-2024-00022.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 while attempting to fix a right coronary artery (rca) and posterior left branch (plb) branch, the doctor placed three (3) stents and had two (2) wires in the vessel.After the deployment of the 3rd stent in the drca, the doctor went to pull the wire out and felt some resistance.After the wire was removed, he noticed that the tip of the wire had detached from the body of the wire.They had to snare out the wire tip and the patient was stable.The procedure performed was a percutaneous transluminal coronary angioplasty (ptca of the rca/plb.The estimated blood loss was less than 250cc's.The reported event did not result in patient injury and/or require medical or surgical intervention.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide an update to sections d9 and d10, and to provide the completed investigation results.The sample was received by ashitaka factory on july 22, 2024.However, since it was a competitor's guidewire, we answer "the actual sample is not available".History investigation of the product with the involved product code/lot number found no anomaly in the manufacturing record and the shipping inspection record.No other similar report was found in the past complaint file.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 clarify the cause of occurrence.Ashitaka factory has been making efforts in maintaining the quality of this product by performing following controls.After 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.In the manufacturing process, pulling strength test is performed on 100% basis to confirm that there is no anomaly in the strength.In the shipping inspection, pulling strength is measured on sampling basis per product code/lot to confirm that there is no anomaly in strength.Instructions for use (ifu) of this product includes the following warning: " [warnings] 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.".

• Brand Name: RUNTHROUGH NS
• Common Device Name: 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 ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 4103927218
• MDR Report Key: 19808586
• Report Number: 9681834-2024-00128
• Device Sequence Number: 7386855
• Product Code: DQX
• UDI-Device Identifier: 04987350734709
• UDI-Public: (01)04987350734709(17)260630(10)230731
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2024

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 Expiration Date: 06/30/2026
• Device Model Number: 25-5211
• Device Catalogue Number: TW*AS418XHW
• Device Lot Number: 230731
• 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: 06/26/2024
• Supplement Date Received by Manufacturer: 07/21/2024
• Initial Report FDA Received Date: 07/23/2024
• Supplement Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/31/2023
• 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: BMW WIRE.; TRAPPER.; TREK BALLOONS.; XIENCE STENTS.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 79 YR
• Patient Sex: Female