Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FARAPULSE, INC. FARADRIVE STEERABLE SHEATH CLEAR; VASCULAR GUIDE-CATHETER, SINGLE-USE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

FARAPULSE, INC. FARADRIVE STEERABLE SHEATH CLEAR; VASCULAR GUIDE-CATHETER, SINGLE-USE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pericardial Effusion (3271)
Event Date 01/31/2024
Event Type  Injury  
Manufacturer Narrative
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 during a pulmonary vein isolation (pvi) procedure to treat atrial fibrillation using a faradrive steerable sheath clear the patient experienced a pericardial effusion.After the lock fell to the right, the sheath was moved to the left.The pericardial effusion was discovered only when the final transesophageal echocardiogram (tee) was done.The procedure was completed successfully.It is unknown if any intervention took place to resolve the complication, but the patient was expected to recover after the procedure.The device is not expected to be returned for analysis.
 
Manufacturer Narrative
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 during a pulmonary vein isolation (pvi) procedure to treat atrial fibrillation using a faradrive steerable sheath clear the patient experienced a pericardial effusion.After the lock fell to the right, the sheath was moved to the left.The pericardial effusion was discovered only when the final transesophageal echocardiogram (tee) was done.The procedure was completed successfully.It is unknown if any intervention took place to resolve the complication, but the patient was expected to recover after the procedure.The device is not expected to be returned for analysis.It was further reported that the faradrive sheath was positioned too far to the right and an attempt was made to steer left without the dilator inserted.
 
Event Description
It was reported that during a pulmonary vein isolation (pvi) procedure to treat atrial fibrillation using a faradrive steerable sheath clear the patient experienced a pericardial effusion.After the lock fell to the right, the sheath was moved to the left.The pericardial effusion was discovered only when the final transesophageal echocardiogram (tee) was done.The procedure was completed successfully.It is unknown if any intervention took place to resolve the complication, but the patient was expected to recover after the procedure.The device is not expected to be returned for analysis.
 
Manufacturer Narrative
Device evaluated by manufacturer: the faradrive was returned for analysis.Functional testing was performed.Steering/deflecting the sheath was functional, and flushing through the irrigation line was successful.The device failed leak testing, and microscopy revealed a tear in the outer valve, indicating that it was unlikely to seal properly.This finding is considered unrelated to the pericardial effusion that occurred during the procedure.With all the available information, boston scientific concludes the reported event of pericardial effusion is a known inherent risk of device due to the information provided in the instructions for use of the device.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
FARADRIVE STEERABLE SHEATH CLEAR
Type of Device
VASCULAR GUIDE-CATHETER, SINGLE-USE
Manufacturer (Section D)
FARAPULSE, INC.
3715 haven avenue
suite 110
menlo park CA 94025
Manufacturer (Section G)
CENTERPOINT SYSTEMS
3338 parkway blvd
west valley city UT 84119
Manufacturer Contact
timothy degroot
4100 hamline avenue north
dc a330
saint paul, MN 55112
6515826168
MDR Report Key18794247
MDR Text Key336397005
Report Number2124215-2024-07253
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 05/09/2024
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
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/31/2024
Initial Date FDA Received02/27/2024
Supplement Dates Manufacturer Received02/27/2024
04/25/2024
Supplement Dates FDA Received03/21/2024
05/09/2024
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
-
-