MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAMIC XT; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number M0042011010

Device Problem Signal Artifact/Noise (1036)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/27/2020

Event Type  malfunction  

Event Description

Incident description: coronary sinus (cs) catheter electrodes had a lot of fragmented signals (noise).We switched cables and pin box, but the problem persisted.We replaced the catheter with a new deca, and the issue resolved.The procedure was carried out with no complications.

• Brand Name: DYNAMIC XT
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10539885
• MDR Text Key: 207188129
• Report Number: 10539885
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 08714729877615
• UDI-Public: (01)08714729877615(17)230602(10)2554715
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/09/2020

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
• Device Operator: Health Professional
• Device Model Number: M0042011010
• Device Lot Number: 2554715
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/09/2020
• Event Location: Hospital
• Date Report to Manufacturer: 09/16/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25915 DA
• Patient Weight: 80