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

Model Number M0042011010

Device Problems Signal Artifact/Noise (1036); Communication or Transmission Problem (2896)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/25/2017

Event Type  malfunction  

Event Description

A catheter was removed from packaging in the usual practice, it was then inserted through the sheath as per normal practice by the doctor.However the electrograms came across junky ¿ all artifact.So a cable was removed and replaced with a new one, but it didn't fix the artifact.Another catheter was opened and used (diff lot, #20718516) it worked just fine patient tolerated procedure not affected by the issue.

• Brand Name: DYNAMIC XT¿
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; conor dolan; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 6910614
• MDR Text Key: 88201140
• Report Number: 6910614
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/30/2020
• Device Model Number: M0042011010
• Device Lot Number: 20711251
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/14/2017
• Event Location: Hospital
• Date Report to Manufacturer: 09/14/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 72 YR