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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOSENSE WEBSTER INC CELSIUS¿ ELECTROPHYSIOLOGY CATHETER; ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION
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BIOSENSE WEBSTER INC CELSIUS¿ ELECTROPHYSIOLOGY CATHETER; ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION Back to Search Results
Catalog Number D7TFL252RT
Device Problems Manufacturing, Packaging or Shipping Problem (2975); Material Protrusion/Extrusion (2979); Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/14/2023
Event Type  malfunction  
Event Description
It was reported that a patient underwent an atrioventricular nodal ablation procedure with a celsius¿ electrophysiology catheter and the device was bent with a gap that exposed internal metals.It was reported that when the celsius¿ electrophysiology catheter was removed from the packaging, the catheter was discovered to be visibly bent.The caller stated that there was a gap in the blue material on the celsius¿ electrophysiology catheter and metal was exposed.They replaced the catheter and the procedure continued.
 
Manufacturer Narrative
On (b)(6) 2023, the bwi product analysis lab received the complaint device for evaluation.The product analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster inc., or its employees that the report constitutes an admission that the product, biosense webster inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
 
Manufacturer Narrative
It was reported that a patient underwent an atrioventricular nodal ablation procedure with a celsius¿ electrophysiology catheter and the device was bent with a gap that exposed internal metals.It was reported that when the celsius¿ electrophysiology catheter was removed from the packaging, the catheter was discovered to be visibly bent.The caller stated that there was a gap in the blue material on the celsius¿ electrophysiology catheter and metal was exposed.They replaced the catheter and the procedure continued.Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.Visual inspection, deflection, and tilt test of the returned device were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.No wires exposed were observed.The anchor window was observed correctly.A tilt test was performed and the tip deviation was within the allowable range of 10 degrees of freedom.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The issues reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
 
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Brand Name
CELSIUS¿ ELECTROPHYSIOLOGY CATHETER
Type of Device
ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION
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 32599
MX   32599
Manufacturer Contact
kate karberg
31 technology dr
irvine, CA 92618
3035526892
MDR Report Key17511085
MDR Text Key321272062
Report Number2029046-2023-01760
Device Sequence Number1
Product Code LPB
UDI-Device Identifier10846835000429
UDI-Public10846835000429
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P950005/S1
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 09/07/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/11/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberD7TFL252RT
Device Lot Number31004782M
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/09/2023
Is the Reporter a Health Professional? No
Date Manufacturer Received08/30/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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