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

Model Number	TW*DS418FH
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920)
Health Effect - Clinical Codes	Blood Loss (2597); Device Embedded In Tissue or Plaque (3165)
Date of Event	09/04/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that while approaching a coronary, in-stent restenosis, in the left main, the 180 cm length runthrough hypercoat became caught/jailed behind the stent strut as the wire was advanced; subsequently the wire separated approximately 10cm from the distal tip of the wire.The remainder of the proximal aspect of the wire was removed; however, the distal segment of the wire remains lodged behind the stent strut and left main vessel wall.Additionally, the remaining proximal segment of the wire is circling the opposing, contralateral aortic root.A snare was used to snare the wire and retrieve without success.The patient was turned down for surgery.Another attempt to retrieve the wire may be made on a later date.Blood loss was less than 250 cc.The patient's condition was stable.Calcified vasculature, previous by-pass patient, left main in-stent restenosis.The procedure outcome was unsatisfactory.Additional information was received on 09sep2019.The procedure to remove the wire was performed on (b)(6) 2019, with partial retrieval of the spring coil segment of the wire.The remaining distal segment of the wire would not release from the stent strut.The attending physician chose to stent over and oppose the wire up against the wall of the left main segment of the artery.

• 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: 9110949
• Report Number: 2243441-2019-00095
• Device Sequence Number: 3762139
• Product Code: DQX
• UDI-Device Identifier: 04987350720986
• UDI-Public: 04987350720986
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/24/2019
• Report Date (Section F): 09/24/2019

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: 12/31/2021
• Device Model Number: TW*DS418FH
• Device Catalogue Number: 25-3011
• Device Lot Number: 190124
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/05/2019
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/09/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 71
• Date Report Sent to FDA: 09/24/2019