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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION POLARIS X; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
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BOSTON SCIENTIFIC CORPORATION POLARIS X; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING Back to Search Results
Model Number 86080
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Tamponade (2226); Pericardial Effusion (3271); Pericarditis (4448)
Event Date 07/13/2021
Event Type  Injury  
Manufacturer Narrative
Age at time of event: 70's.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.
 
Event Description
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.
 
Manufacturer Narrative
Patient code corrected from e0620: pericarditis to e0605: cardiac tamponade.Age at time of event: 70's.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.
 
Event Description
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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Brand Name
POLARIS X
Type of Device
CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key12307425
MDR Text Key266017151
Report Number2134265-2021-10268
Device Sequence Number1
Product Code DRF
Combination Product (y/n)N
PMA/PMN Number
K003452
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 09/21/2021
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 Model Number86080
Device Catalogue Number86080
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/13/2021
Initial Date FDA Received08/11/2021
Supplement Dates Manufacturer Received08/23/2021
Supplement Dates FDA Received09/21/2021
Patient Sequence Number1
Treatment
BAYLIS SUREFLEX SHEATH; BAYLIS SUREFLEX SHEATH; BAYLIS TRANSAPICAL NEEDLE; BAYLIS TRANSAPICAL NEEDLE; INTELLAMAP ORION MAPPING CATHETER; INTELLAMAP ORION MAPPING CATHETER; INTELLANAV MIFI OPEN-IRRIGATED; INTELLANAV MIFI OPEN-IRRIGATED; RHYTHMIA MAPPING SYSTEM; RHYTHMIA MAPPING SYSTEM; SIEMENS ACCUSON ICE 8FR; SIEMENS ACCUSON ICE 8FR; ST JUDE LIVEWIRE DUODECA; ST JUDE LIVEWIRE DUODECA; ST JUDE SRO SHEATH; ST JUDE SRO SHEATH; ST JUDE SUPREME; ST JUDE SUPREME; BAYLIS SUREFLEX SHEATH; BAYLIS TRANSAPICAL NEEDLE; INTELLAMAP ORION MAPPING CATHETER; INTELLANAV MIFI OPEN-IRRIGATED; RHYTHMIA MAPPING SYSTEM; SIEMENS ACCUSON ICE 8FR; ST JUDE LIVEWIRE DUODECA; ST JUDE SRO SHEATH; ST JUDE SUPREME
Patient Outcome(s) Required Intervention;
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