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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Pneumothorax (2012); Pericardial Effusion (3271)

Event Date 03/07/2019

Event Type  Injury  

Event Description

It was reported that a pericardial effusion and pneumothorax occurred.During an ablation procedure for atrial tachycardia (at), they first performed a map of the left atrium (la) with an intellamap orion catheter.Earliest activation was under the right superior pulmonary vein (rspv), no clear qs.They mapped the right atrium (ra) and a clear focus was seen on the junction between the superior vena cava (svc) and ra.They then ablated with an intellanav mifi open-irrigated ablation catheter at 30 watts and tachycardia stopped after 20 seconds.Two more short burns were performed.Induction of tachycardia was not possible.A new map of the ra was done in sinus rhythm and further induction was attempted without success.The procedure was ended and the catheters and sheaths were removed.Shortly after that, a blood pressure drop was observed.The patient was in sinus rhythm 110 bpm.The anesthesiologist performed cpi.With transesophageal echocardiography (tte) fluid was observed in the pericardium.The electrophysiologist performed a pericard puncture, but punctured the lung during the attempt.The situation got worse and a thorax drain was placed by the cardiac surgeon.The patient was stabilized after that and transferred to the intensive care unit (icu).Later that day, while the patient was in the icu, a new attempt to aspirate fluid from the epicardial space was done with success.The patient's blood pressure then returned to normal.It was unclear if any of the catheters contributed to the event.There was no problem during mapping and ablation.The cause could be related to transseptal puncture.There was never during the procedure a notification about resistance while manipulating the catheters.

Manufacturer Narrative

The device was returned for analysis.Inspection shows no visible abnormalities.The device passes the curving test.There was no issue with deploying the array.The 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 and pneumothorax occurred.During an ablation procedure for atrial tachycardia (at), they first performed a map of the left atrium (la) with an intellamap orion catheter.Earliest activation was under the right superior pulmonary vein (rspv), no clear qs.They mapped the right atrium (ra) and a clear focus was seen on the junction between the superior vena cava (svc) and ra.They then ablated with an intellanav mifi open-irrigated ablation catheter at 30 watts and tachycardia stopped after 20 seconds.Two more short burns were performed.Induction of tachycardia was not possible.A new map of the ra was done in sinus rhythm and further induction was attempted without success.The procedure was ended and the catheters and sheaths were removed.Shortly after that, a blood pressure drop was observed.The patient was in sinus rhythm 110 bpm.The anesthesiologist performed cpi.With transesophageal echocardiography (tte) fluid was observed in the pericardium.The electrophysiologist performed a pericard puncture, but punctured the lung during the attempt.The situation got worse and a thorax drain was placed by the cardiac surgeon.The patient was stabilized after that and transferred to the intensive care unit (icu).Later that day, while the patient was in the icu, a new attempt to aspirate fluid from the epicardial space was done with success.The patient's blood pressure then returned to normal.It was unclear if any of the catheters contributed to the event.There was no problem during mapping and ablation.The cause could be related to transseptal puncture.There was never during the procedure a notification about resistance while manipulating the catheters.

• 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: 8439395
• MDR Text Key: 139423529
• Report Number: 2134265-2019-02810
• 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: 05/15/2019

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: 11/22/2019
• Device Model Number: 87035
• Device Catalogue Number: 87035
• Device Lot Number: 0022978458
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2019
• Initial Date Manufacturer Received: 03/07/2019
• Initial Date FDA Received: 03/21/2019
• Supplement Dates Manufacturer Received: 04/29/2019
• Supplement Dates FDA Received: 05/15/2019
• Patient Sequence Number: 1
• Treatment: INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER; INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER; INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER
• Patient Outcome(s): Hospitalization; Required Intervention