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 Thrombosis (2100); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 04/11/2019

Event Type  Injury  

Event Description

It was reported that the patient experienced a cardiac perforation, pericardial effusion and thrombosis.On (b)(6) 2019, an ablation procedure was performed for persistent atrial fibrillation (af).The catheters inserted were a non-boston scientific (bsc) inner fr.- braided deflectable sheath, a non-bsc trans-septal sheath, a non-bsc diagnostic catheter in right atrium, a non-bsc ice catheter in right atrium, a bsc intellanav mifi open-irrigated catheter inserted in the left atrial appendage via sl0 8.5 inner fr - braided fixed 87cm sheath and a bsc intellamap orion catheter inserted in the left atrium via the non-bsc inner fr.- braided deflectable sheath.The activated clotting time (act) was greater than 300 seconds.Irrigation flow rate was a 2cc per minute maintenance rate.No radiofrequency (rf) lesions were delivered.The non-bsc diagnostic catheter and ice catheters were placed and double transseptal access was achieved with no ice documented events.The initial left atrial 3d model began, both the orion and the intellanav catheters were actively used to create the surface.After a few minutes of mapping with the orion, the electrophysiologist (ep) was not able to cannulate the right inferior pulmonary vein (ripv) or left inferior pulmonary vein (lipv).Resistance was felt with both the ablation and orion catheters during surface creation.The physician then pulled the intellanav catheter away from the left atrial appendage (laa) and began to probe for the ostia of both the lipv and ripv.Soon after this, the patient developed a pericardial effusion requiring urgent pericardiocentesis.The patient left the room in stable condition at approximately 13:30 eastern standard time (est).As of 14:50 est, the patient was extubated, conscience and alert.The physician felt that the intellanav mifi oi ablation catheter, while in the left atrial appendage, was the most likely catheter to have caused the perforation.The patient was seen in the office by the physician on (b)(6) 2019 and was fully recovered with no health issues related to this event.

Manufacturer Narrative

The device was returned for analysis.Inspection showed no visible abnormalities.The device passes the curve test.There was no issue with deploying the array.The electrical test was performed and the device passed the test.The device passed all relevant testing/inspection.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.

Event Description

It was reported that the patient experienced a cardiac perforation, pericardial effusion and thrombosis.On (b)(6) 2019, an ablation procedure was performed for persistent atrial fibrillation (af).The catheters inserted were a non-boston scientific (bsc) inner fr.Braided deflectable sheath, a non-bsc trans-septal sheath, a non-bsc diagnostic catheter in right atrium, a non-bsc ice catheter in right atrium, a bsc intellanav mifi open-irrigated catheter inserted in the left atrial appendage via sl0 8.5 inner fr.Braided fixed 87cm sheath and a bsc intellamap orion catheter catheter inserted in the left atrium via the non-bsc inner fr.Braided deflectable sheath.The activated clotting time (act) was greater than 300 seconds.Irrigation flow rate was a 2cc per minute maintenance rate.No radiofrequency (rf) lesions were delivered.The non-bsc diagnostic catheter and ice catheters were placed and double transseptal access was achieved with no ice documented events.The initial left atrial 3d model began, both the orion and the intellanav catheters were actively used to create the surface.After a few minutes of mapping with the orion, the electrophysiologist (ep) was not able to cannulate the right inferior pulmonary vein (ripv) or left inferior pulmonary vein (lipv).Resistance was felt with both the ablation and orion catheters during surface creation.The physician then pulled the intellanav catheter away from the left atrial appendage (laa) and began to probe for the ostia of both the lipv and ripv.Soon after this, the patient developed a pericardial effusion requiring urgent pericardiocentesis.The patient left the room in stable condition at approximately 13:30 eastern standard time (est).As of 14:50 est, the patient was extubated, conscience and alert.The physician felt that the intellanav mifi oi ablation catheter, while in the left atrial appendage, was the most likely catheter to have caused the perforation.The patient was seen in the office by the physician on (b)(6) 2019 and was fully recovered with no health issues related to this event.

• 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: 8574066
• MDR Text Key: 143847112
• Report Number: 2134265-2019-04776
• 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,health
• Type of Report: Initial,Followup
• Report Date: 06/12/2019

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: 04/22/2020
• Device Model Number: 87035
• Device Catalogue Number: 87035
• Device Lot Number: 0023404743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2019
• Initial Date Manufacturer Received: 04/11/2019
• Initial Date FDA Received: 05/02/2019
• Supplement Dates Manufacturer Received: 05/24/2019
• Supplement Dates FDA Received: 06/12/2019
• Patient Sequence Number: 1
• Treatment: INTELLANAV MIFI OPEN-IRRIGATED; INTELLANAV MIFI OPEN-IRRIGATED; INTELLANAV MIFI OPEN-IRRIGATED
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR