MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) INTELLAMAP ORION¿; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number M004RC64S0

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Tamponade (2226)

Event Date 12/04/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Same case as 2134265-2017-12498.It was reported pericardial tamponade occurred.An intellanav mifi oi ablation catheter and an intellamap orion¿ mapping catheter were selected for use during an atrial tachycardia (at) ablation procedure.After re-ablation of the pulmonary veins and ablation of the at at the roof from the left atrium, the patient¿s blood pressure became low.A transthoracic echocardiogram was performed which revealed pericardial tamponade.The ablation catheter and mapping catheter were removed from the left atrium.A pericardial puncture was performed and about one liter of blood was removed.The cause of the tamponade was not determined; it was unknown if either catheter caused or contributed.The procedure was aborted following the puncture.The patient was stable and awake, and was transferred for further observation in the intensive care unit.There were no further patient complications.

Manufacturer Narrative

Device evaluated by mfr: the device was received for analysis after decontamination; the upn matches the upn provided by the customer.Visual inspection did not reveal any abnormalities.The device passed electrical testing; a magnetic sensor resistance test was performed and both pairs were within specification.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is anticipated procedural complication as the event is due to a known physiological effect of the procedure noted within the directions for use, and/or device labeling.(b)(4).

Event Description

Same case as 2134265-2017-12498.It was reported pericardial tamponade occurred.An intellanav mifi oi ablation catheter and an intellamap orion mapping catheter were selected for use during an atrial tachycardia (at) ablation procedure.After re-ablation of the pulmonary veins and ablation of the at the roof from the left atrium, the patient¿s blood pressure became low.A transthoracic echocardiogram was performed which revealed pericardial tamponade.The ablation catheter and mapping catheter were removed from the left atrium.A pericardial puncture was performed and about one liter of blood was removed.The cause of the tamponade was not determined; it was unknown if either catheter caused or contributed.The procedure was aborted following the puncture.The patient was stable and awake, and was transferred for further observation in the intensive care unit.There were no further patient complications.

• Brand Name: INTELLAMAP ORION¿
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7128287
• MDR Text Key: 95222503
• Report Number: 2134265-2017-12499
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 08714729841968
• UDI-Public: 08714729841968
• Combination Product (y/n): N
• PMA/PMN Number: K122461
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/04/2017

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: 09/19/2018
• Device Model Number: M004RC64S0
• Device Catalogue Number: RC64S
• Device Lot Number: 21154725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2017
• Initial Date FDA Received: 12/19/2017
• Supplement Dates Manufacturer Received: 01/23/2018
• Supplement Dates FDA Received: 02/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Weight: 90