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 High impedance (1291); Data Problem (3196)

Patient Problems Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 06/23/2020

Event Type  Injury  

Manufacturer Narrative

The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

During an ischemic vt mapping procedure, a transseptal puncture was performed in order to advance an orion mapping catheter into the left ventricle.The puncture was performed utilizing a non-boston scientific sheath, without a needle.Access to the left ventricle was obtained via the right atrium, to the left atrium, to the left ventricle.However, rhythmia displayed high impedance on 50 of the orion electrodes; therefore, mapping in the left ventricle wasn't possible.In addition, rhythmia indicated poor tracking quality while mapping the apex.The issue was intermittent and only in the apex area.It was noted that, since visualization of the orion disappeared, the tracking issue must have been with magnetic tracking.Error messages were displayed regarding these issues, but the numerical codes were not available.The patient also had an implantable cardioverter defibrillator (icd).The impedance issue occurred after the catheter was inserted and advanced in the direction of the cardial apex; the issues only occurred close to the apex.The fluoroscopy system was removed, the catheter cable was replaced, and the rhythmia system was rebooted, but the issue did not resolve.Therefore, the orion catheter was replaced and a map of the left ventricle was created.While mapping, it wasn't possible to move the catheter to the septal area of the ventricle and the left lateral wall showed only abnormal low voltage.Furthermore, blood pressure of the patient decreased and transesophageal echocardiography (tee) showed a pericardial effusion.A perforation had occurred, most likely in the left atrium, though there was no visual confirmation regarding the exact location of the perforation.Fluoroscopy had shown the catheter only at the left lateral edge of the heart shadow.The inability to move the catheter to the septal area, and the nature of the map (thin convex shape of the map; almost zero voltage at the left lateral side, respectively lamina parietalis of the pericardium), suggested that most likely the pericardium was accidentally mapped, rather than the left ventricle, which had been the intended mapping area.Therefore, the perforation "must have occurred during the transseptal puncture," before the orion was inserted initially.The procedure was aborted and a pericardiocentesis took place to stabilize the patient.Surgical intervention was not necessary.The patient was stabilized and there was no further patient outcome.There was no allegation or indication that the device issues caused or contributed to the patient's complications.The device is expected to be returned to boston scientific for analysis; however, it has not been received as of the date of this report.

Event Description

During an ischemic vt mapping procedure, a transseptal puncture was performed in order to advance an orion mapping catheter into the left ventricle.The puncture was performed utilizing a non-boston scientific sheath, without a needle.Access to the left ventricle was obtained via the right atrium, to the left atrium, to the left ventricle.However, rhythmia displayed high impedance on 50 of the orion electrodes; therefore, mapping in the left ventricle wasn't possible.In addition, rhythmia indicated poor tracking quality while mapping the apex.The issue was intermittent and only in the apex area.It was noted that, since visualization of the orion disappeared, the tracking issue must have been with magnetic tracking.Error messages were displayed regarding these issues, but the numerical codes were not available.The patient also had an implantable cardioverter defibrillator (icd).The impedance issue occurred after the catheter was inserted and advanced in the direction of the cardial apex; the issues only occurred close to the apex.The fluoroscopy system was removed, the catheter cable was replaced, and the rhythmia system was rebooted, but the issue did not resolve.Therefore, the orion catheter was replaced and a map of the left ventricle was created.While mapping, it wasn't possible to move the catheter to the septal area of the ventricle and the left lateral wall showed only abnormal low voltage.Furthermore, blood pressure of the patient decreased and transesophageal echocardiography (tee) showed a pericardial effusion.A perforation had occurred, most likely in the left atrium, though there was no visual confirmation regarding the exact location of the perforation.Fluoroscopy had shown the catheter only at the left lateral edge of the heart shadow.The inability to move the catheter to the septal area, and the nature of the map (thin convex shape of the map; almost zero voltage at the left lateral side, respectively lamina parietalis of the pericardium), suggested that most likely the pericardium was accidentally mapped, rather than the left ventricle, which had been the intended mapping area.Therefore, the perforation "must have occurred during the transseptal puncture," before the orion was inserted initially.The procedure was aborted and a pericardiocentesis took place to stabilize the patient.Surgical intervention was not necessary.The patient was stabilized and there was no further patient outcome.There was no allegation or indication that the device issues caused or contributed to the patient's complications.The device is expected to be returned to boston scientific for analysis.Additional information received reported there had only been an issue with the first orion used.There were no performance issues with the rhythmia system or the second orion used.No catheter was involved in the perforation.The perforation occurred, most likely, during the transseptal puncture, before any catheters were inserted.

Manufacturer Narrative

The returned device was reported for a serious injury of pericardial infusion due to tracking and high impedance; the reported failure was not confirmed through analysis.The device passed all visual and functional testing.A device history record (dhr) review was performed and no deviation was found.No manufacturing related contributions are suspected to have contributed to the reported event.Based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications/instruction for use.Based on all available information, the complaint investigation conclusion code is: known inherent risk of device since the device was tested and did not show any errors related to complaint and the complaint is a known or anticipated risk in using the device.

• 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: 10264281
• MDR Text Key: 198527858
• Report Number: 2134265-2020-09243
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 09/24/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/12/2021
• Device Model Number: 87035
• Device Catalogue Number: 87035
• Device Lot Number: 0024267140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Initial Date Manufacturer Received: 06/23/2020
• Initial Date FDA Received: 07/13/2020
• Supplement Dates Manufacturer Received: 08/26/2020
• Supplement Dates FDA Received: 09/24/2020
• Patient Sequence Number: 1
• Treatment: INTELLAMAP ORION CATHETER; INTELLAMAP ORION CATHETER; INTELLAMAP ORION CATHETER
• Patient Outcome(s): Required Intervention