MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number 87035

Device Problems Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896)

Patient Problems Cardiac Arrest (1762); Heart Failure (2206)

Event Date 12/18/2019

Event Type  Injury  

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

Event Description

It was reported that heart failure occurred.During an ablation procedure for recurrent ventricular tachycardia, after positioning the intellamap orion catheter into the ventricle, it was observed that the catheter electrodes had no signal.The physician was about to switch out the catheter when the patient experienced acute left heart failure.The procedure was cancelled.Details of the medical intervention required for the patient's acute left heart failure were not provided.It was noted that the patient was stable and the event had resolved without complication or damage.

Event Description

It was reported that heart failure occurred.During an ablation procedure for recurrent ventricular tachycardia, after positioning the intellamap orion catheter into the ventricle, it was observed that the catheter electrodes had no signal.The physician was about to switch out the catheter when the patient experienced acute left heart failure.The procedure was cancelled.Details of the medical intervention required for the patient's acute left heart failure were not provided.It was noted that the patient was stable and the event had resolved without complication or damage.It was additionally reported that an error message was displayed (details unavailable) though there had been no issues when physically connecting the catheter.The patient had not yet recovered, but the physician planned to perform the procedure again in the future.

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

Event Description

It was reported that heart failure occurred.During an ablation procedure for recurrent ventricular tachycardia, after positioning the intellamap orion catheter into the ventricle, it was observed that the catheter electrodes had no signal.The physician was about to switch out the catheter when the patient experienced acute left heart failure.The procedure was cancelled.Details of the medical intervention required for the patient's acute left heart failure were not provided.It was noted that the patient was stable and the event had resolved without complication or damage.It was additionally reported that an error message was displayed (details unavailable) though there had been no issues when physically connecting the catheter.The patient had not yet recovered, but the physician planned to perform the procedure again in the future.Additional information clarified that the patient experienced cardiac arrest.The patient did not suffer any subsequent harm as a result and returned to a normal state of health.

Manufacturer Narrative

Correction: f.10.Patient code.It was indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.

Event Description

It was reported that heart failure occurred.During an ablation procedure for recurrent ventricular tachycardia, after positioning the intellamap orion catheter into the ventricle, it was observed that the catheter electrodes had no signal.The physician was about to switch out the catheter when the patient experienced acute left heart failure.The procedure was cancelled.Details of the medical intervention required for the patient's acute left heart failure were not provided.It was noted that the patient was stable and the event had resolved without complication or damage.It was additionally reported that an error message was displayed (details unavailable) though there had been no issues when physically connecting the catheter.The patient had not yet recovered, but the physician planned to perform the procedure again in the future.Additional information clarified that the patient experienced cardiac arrest.The patient did not suffer any subsequent harm as a result and returned to a normal state of health.Corrected information from the field: "the patient always had a cough during surgery" and the patient event was acute left heart failure and not cardiac arrest.

• Brand Name: INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER
• 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: 9558574
• MDR Text Key: 173970135
• Report Number: 2134265-2019-16511
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 08714729841968
• UDI-Public: 08714729841968
• Combination Product (y/n): N
• PMA/PMN Number: K143481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2020
• Device Model Number: 87035
• Device Catalogue Number: 87035
• Device Lot Number: 0023583390
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 78