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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported a broken runthrough wire tip that occurred during a percutaneous coronary intervention (pci).According to the team they had a runthrough wire tip breakoff during a procedure.The patient remained stable during the procedure and no harm to the patient was done.The doctor was placing a stent in a heavy calicified left anterior descending artery (lad).He had a runthrough ns wire down the lad and a sion blue wire down the diag.The sion blue wire was pulled back before stent deployment.Once stent (boston scientific synergy) was deployed and vessel was post dilated ( boston emerge) the runthrough wire was removed.Upon removing the tip of the wire came off in the left main.The decision was made to pin the wire to wall with an additional stent (boston scientific megatron).The estimated blood loss was less than 250cc.A coronary artery stenting and angioplasty was required to trap the wire tip in a secure location.

• 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: 19544603
• Report Number: 2243441-2024-00018
• Device Sequence Number: 7681797
• Product Code: DQX
• UDI-Device Identifier: 04987350779373
• UDI-Public: 04987350779373
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/16/2024
• Report Date (Section F): 06/16/2024

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: 09/30/2026
• Device Model Number: N/A
• Device Catalogue Number: 25-1011
• Device Lot Number: 231031Y
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/15/2024
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/21/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/16/2024
• 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: BOSTON SCIENTIFIC MEGATRON; BOSTON SCIENTIFIC SYNERGY; SION BLUE WIRE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Date Report Sent to FDA: 06/16/2024