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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARSHEATH; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
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BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARSHEATH; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING Back to Search Results
Lot Number 0031868843
Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Air Embolism (1697); Non specific EKG/ECG Changes (1817)
Event Date 11/09/2023
Event Type  Death  
Event Description
It was reported that during a cryo-ablation procedure to treat atrial fibrillation (a fib) using a polarsheath the patient experienced an air embolism in the left atrium and ventricle.The procedure was cancelled in order to perform interventions.An intra-aortic balloon pump was implanted, and the patient was connected to extracorporeal membrane oxygenation system.Following the interventions, it was reported the patient was still unconscious at the hospital.The sheath is not expected to be returned as it was disposed of by the site.
 
Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
 
Manufacturer Narrative
Based upon analysis of all available information, bsc's investigation found no evidence to indicate that the air embolism was related to product performance of the polarsheath.There was no report of any device performance concerns.The patient events reported in the complaint are known potential adverse events related with the use of the device and are noted within the indications/instructions for use (ifu).Therefore, all compiled information on this investigation determines that the most probable cause is known inherent risk of device since the complaint patient events reported by the physician is known and documented in the labeling.The polarsheath's instructions for use state "potential adverse events associated with cannulation of the peripheral vasculature and intracardiac placement of the polarsheath sheath and dilator may include the following conditions: injury due to embolism/ thromboembolism/air embolism/foreign body embolism:".
 
Event Description
It was reported that during a cryo-ablation procedure to treat atrial fibrillation (a fib) using a polarsheath the patient experienced an air embolism in the left atrium and ventricle.The procedure was cancelled in order to perform interventions.An intra-aortic balloon pump was implanted, and the patient was connected to extracorporeal membrane oxygenation system.Following the interventions, it was reported the patient was still unconscious at the hospital.The sheath is not expected to be returned as it was disposed of by the site.It was later reported that the died on (b)(6) 2023 after their blood pressure dropped suddenly.
 
Manufacturer Narrative
The sheath was not returned to boston scientific for analysis; however, investigators were able to use the information provided from the field.Based on all available information, although the reported event of air embolism is a known inherent risk of polar sheath, the ultimate cause of the air embolism was determined to most likely be user error.While the instructions for use do state: "potential adverse events associated with cannulation of the peripheral vasculature and intracardiac placement of the polar sheath sheath and dilator may include the following conditions: embolism (air, gas, thrombo)".The same instructions also state "regulator flushing of the polar sheath.Is recommended to prevent blood stagnation, clots, emboli, and serious patient injury." and "continuous irrigation is recommended while the catheter is inserted to replenish fluid displaced out of the sheath by catheter movement.".
 
Event Description
It was reported that during a cryo-ablation procedure to treat atrial fibrillation (a fib) using a polar sheath the patient experienced an air embolism in the left atrium and ventricle.The procedure was cancelled in order to perform interventions.An intra-aortic balloon pump was implanted, and the patient was connected to extracorporeal membrane oxygenation system.Following the interventions, it was reported the patient was still unconscious at the hospital.The sheath is not expected to be returned as it was disposed of by the site.It was later reported that the died on (b)(6) 2023 after their blood pressure dropped suddenly.Additionally, it was noted that the irrigation bag for the polar sheath was found to be empty after st segment elevation was observed.This occurred sometime after the catheter had been introduced into the sheath.
 
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Brand Name
POLARSHEATH
Type of Device
CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
Manufacturer (Section D)
BOSTON SCIENTIFIC DE COSTA RICA S.R.L.
302 parkway
global park, la aurora
heredia
CS 
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
302 parkway, global park
la aurora - heredia
CS  
Manufacturer Contact
timothy degroot
4100 hamline avenue north
dc a330
saint paul, MN 55112
6515826168
MDR Report Key18242566
MDR Text Key329430488
Report Number2124215-2023-66252
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeTH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 01/24/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot Number0031868843
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/09/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/22/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Hospitalization; Death;
Patient Age54 YR
Patient SexMale
Patient Weight100 KG
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