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

Model Number 87035

Device Problem Data Problem (3196)

Patient Problems Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)

Event Date 03/12/2019

Event Type  Injury  

Event Description

It was reported that a pericardial effusion occurred.During an ablation procedure for atrial fibrillation, an intellamap orion high resolution mapping catheter and non-boston scientific (bsc) steerable sheath were selected for use.The insertion sites were the right and left atrium (la).Anticoagulation therapy was used intra-procedural.The ablation parameters were set at 30watts.During the re-map of the la, the tracking of the orion did not work, but the signals were still normal.They switched the catheter to a new one and everything worked in normal way.No char or coagulum was noted on the device.However, the patient's blood pressure dropped and a pericardial effusion occurred during the procedure.No perforation occurred.The procedure was not successful in completing the intended ablation as the pulmonary veins were too big.The patient was stable following the procedure.

Manufacturer Narrative

The device was returned for analysis.Visual inspection showed a kink located approximately 4cm from the distal tip.An electrical test was performed and the device passed the test.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.

Event Description

It was reported that a pericardial effusion occurred.During an ablation procedure for atrial fibrillation, an intellamap orion high resolution mapping catheter and non-boston scientific (bsc) steerable sheath were selected for use.The insertion sites were the right and left atrium (la).Anticoagulation therapy was used intra-procedural.The ablation parameters were set at 30watts.During the re-map of the la, the tracking of the orion did not work, but the signals were still normal.They switched the catheter to a new one and everything worked in normal way.No char or coagulum was noted on the device.However, the patient's blood pressure dropped and a pericardial effusion occurred during the procedure.No perforation occurred.The procedure was not successful in completing the intended ablation as the pulmonary veins were too big.The patient was stable following the procedure.

• Brand Name: INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 8495138
• MDR Text Key: 141315712
• Report Number: 2134265-2019-03648
• 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: 05/28/2019

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: 07/16/2019
• Device Model Number: 87035
• Device Catalogue Number: 87035
• Device Lot Number: 0022382557
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2019
• Initial Date Manufacturer Received: 03/12/2019
• Initial Date FDA Received: 04/09/2019
• Supplement Dates Manufacturer Received: 04/29/2019
• Supplement Dates FDA Received: 05/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other