MAUDE Adverse Event Report: CORDIS CORPORATION SV WIRE; WIRE, GUIDE, CATHETER

Model Number	503558X
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During the procedure, an sv5 wire was used via the right internal jugular vein, and a piece of the wire broke and dislodged itself in a distal branch of the right pulmonary artery.Patient¿s vital signs remained stable during the procedure.The dr.(doctor) attempted to remove the broken piece of wire multiple times with different snaring devices without success, at which point, the dr.Decided the risk of removal will risk harm to the patient in the location that it was in.There was no possibility of device moving elsewhere in the body.

• Brand Name: SV WIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): CORDIS CORPORATION; 14201 n.w. 60th ave; miami lakes FL 33014
• MDR Report Key: 14110731
• Report Number: 14110731
• Device Sequence Number: 5276189
• Product Code: DQX
• UDI-Device Identifier: 10705032056069
• UDI-Public: (01)10705032056069
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/12/2022
• Report Date (Section F): 04/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 503558X
• Device Catalogue Number: 503558X
• Device Lot Number: 35262084
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/14/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/14/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 11 KG
• Patient Race: White
• Date Report Sent to FDA: 04/12/2022