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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOSENSE WEBSTER INC DECANAV ELECTROPHYSIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

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BIOSENSE WEBSTER INC DECANAV ELECTROPHYSIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING Back to Search Results
Model Number R7F282CT
Device Problem Patient Device Interaction Problem (4001)
Patient Problems Cardiac Tamponade (2226); Unspecified Tissue Injury (4559)
Event Date 06/22/2022
Event Type  Injury  
Event Description
It was reported that a 74-year-old female patient underwent an atrial fibrillation (afib) ablation procedure with a decanav electrophysiology catheter.The patient suffered cardiac tamponade requiring pericardiocentesis and prolonged hospitalization.It was reported that the patient had a pericardial effusion, this was confirmed during baseline imaging with the soundstar catheter before getting transeptal access.A pericardiocentesis was done and 350ml of fluid was removed.The patient's blood pressure did drop but after the pericardiocentesis, the blood pressure recovered.The physician thinks the issue may have occurred when they were trying to disconnect the decanav electrophysiology catheter from the carto 3 system, the catheter moved from the coronary sinus (cs) into the right ventricular outflow tract (rvot) when they reconnected the catheter to the patient interface unit (piu).The case continued and was completed.The patient stayed overnight for observation.The caller also states that while giving isoprenyl during the ep study, the intra-aortic blood pressure rose to 220/180 and then increased with the isoprenyl was given.Once the isoprenyl was titrated down and stopped the intra-aortic blood pressure normalized.Additional information was received on the event.No radio frequency catheters were introduced in the body.Decanav electrophysiology catheter was used as mapping catheter.The adverse event was discovered during use of biosense webster products during ep study/diagnostic phase.The physician¿s opinion on the cause of this adverse event was that it was procedure related.The patient outcome of the adverse event was improved.The patient required extended hospitalization because of the adverse event.The physician stated that he found some tissue at the tip of decanav electrophysiology catheter.He sent it for histology evaluation to determine type of tissue.A transseptal puncture was not performed, the effusion found prior to transseptal puncture, during baseline imaging with soundstar catheter.No ablation was performed.The generator information is a smartablate generator kit-us which was not used during the procedure.Soft tissue injury was added for ¿the physician stated that he found some tissue at the tip of decanav.He sent it for histology evaluation to determine type of tissue.¿ should more information become available, it will be reviewed and processed accordingly.
 
Manufacturer Narrative
The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
 
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Brand Name
DECANAV ELECTROPHYSIOLOGY CATHETER
Type of Device
CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
Manufacturer (Section D)
BIOSENSE WEBSTER INC
31 technology drive, suite 200
irvine CA 92618
Manufacturer (Section G)
BIOSENSE WEBSTER INC (JUAREZ)
circuito interior norte
1820parque industrial salvacar
juarez
MX  
Manufacturer Contact
michelleann garcia
31 technology dr
irvine, CA 92618
646591-798
MDR Report Key15033302
MDR Text Key296045144
Report Number2029046-2022-01630
Device Sequence Number1
Product Code DRF
UDI-Device Identifier10846835008807
UDI-Public10846835008807
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K080425
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 07/15/2022
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 NumberR7F282CT
Device Catalogue NumberR7F282CT
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/22/2022
Initial Date FDA Received07/15/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
NON BWI ¿ ABBOTT QUAD POLAR CATHETER; NON BWI ¿ ABBOTT QUAD POLAR CATHETER; NON BWI ¿ ABBOTT QUAD POLAR CATHETER; SMARTABLATE GENERATOR KIT-US; UNK_CARTO 3; UNK_SOUNDSTAR
Patient Outcome(s) Hospitalization; Required Intervention; Life Threatening;
Patient Age74 YR
Patient SexFemale
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