BOSTON SCIENTIFIC CORPORATION INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
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Model Number 87035 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cardiac Tamponade (2226); Pericardial Effusion (3271); Pericarditis (4448)
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Event Date 07/13/2021 |
Event Type
Injury
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Manufacturer Narrative
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Age at time of event:(b)(6).It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
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Event Description
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It was reported that a intellanav mifi open-irrigated, intellamap orion high resolution mapping catheter.And polaris x were used in a left atrial fibrillation line ablation procedure.At the conclusion of the procedure, a 'trivial effusion' was noted.The patient's vitals were stable, equipment was removed and patient was admitted to telemetry.During the night, patient developed cardiac tamponade, an urgent/emergent pericardiocentesis was performed and a drain was left in place.Patient was transferred to the intensive care unit (icu).No additional patient complications were reported.The physician did not attribute the effusion to any specific event or specific product.
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Event Description
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It was reported that a intellanav mifi open-irrigated, intellamap orion high resolution mapping catheter.And polaris x were used in a left atrial fibrillation line ablation procedure.At the conclusion of the procedure, a 'trivial effusion' was noted.The patient's vitals were stable, equipment was removed and patient was admitted to telemetry.During the night, patient developed cardiac tamponade, an urgent/emergent pericardiocentesis was performed and a drain was left in place.Patient was transferred to the intensive care unit (icu).No additional patient complications were reported.The physician did not attribute the effusion to any specific event or specific product.
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Manufacturer Narrative
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Age at time of event: 70's.Correction: patient codes updated from e0620: pericarditis to e0605 cardiac tamponade.The device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.Lot number was not provided; therefore, a ship history of previous lots sent to the customer was reviewed.Device history record (dhr) review of the lots identified found no issues.
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Search Alerts/Recalls
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