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

Model Number	TW*AS430XA
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/26/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the doctor was doing a complex coronary, involving in-stent restenosis and laser atherectomy.He used 2 runthrough wires and both had part of the distal wire break off and stay in the patient.They tried to snare the pieces unsuccessfully.The patient condition was stable at the end of the procedure.There was no surgery; however, they were unable to remove the wire with snare.

• 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: 8896316
• Report Number: 2243441-2019-00067
• Device Sequence Number: 318759
• Product Code: DQX
• UDI-Device Identifier: 04987350703583
• UDI-Public: 04987350703583
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/15/2019
• Report Date (Section F): 08/15/2019

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: 01/31/2020
• Device Model Number: TW*AS430XA
• Device Catalogue Number: 25-1013
• Device Lot Number: 170221
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/26/2019
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/29/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/15/2019
• 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: LASER ATHERECTOMY
• Outcome Attributed to Adverse Event: Other
• Patient Age: 79 YR
• Patient Weight: 71
• Date Report Sent to FDA: 08/15/2019