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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOSENSE WEBSTER INC PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

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BIOSENSE WEBSTER INC PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY Back to Search Results
Model Number D128211
Device Problems Signal Artifact/Noise (1036); Sharp Edges (4013)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/08/2021
Event Type  malfunction  
Manufacturer Narrative
Device evaluation details: the device was returned to biosense webster inc.(bwi) for evaluation.Bwi conducted a visual inspection and electrical evaluation of the returned device.Visual analysis of the returned pentaray nav high-density mapping eco catheter revealed that electrodes #14, #15 and #16 were found misshaped and lifted.Electrical test was performed, and the device failed, no electrical readings were observed on electrodes #014 and #016.A failure analysis was performed and the device was dissected on the tip area.The electrical wires were found broken causing the improper electrical signal.Manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.As part of biosense webster¿s quality process all devices are manufactured, inspected, and released to approved specifications.The instructions for use contain the following warning stated in the carto 3 system manual: ecg noise is typically generated as the result of improper connection of the body surface ecg patch to the patient.This noise is the most significant during ablation.To resolve this situation, verify proper connection.It is recommended to turn off the notch filter for this verification.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(4).
 
Event Description
A patient underwent a cardiac ablation procedure with a pentaray nav high-density mapping eco catheter for which biosense webster¿s product analysis lab (pal) identified electrodes damaged during product analysis.It was initially reported by the customer that there was a loss of signals/egms on poles 13-14 and 15-16.Troubleshooting followed delaying the procedure only a few minutes.They changed the cable without change.They changed the catheter and issue was fixed.There was no patient consequence.The customer¿s reported issue signal noise/loss affecting some channels of the body surface (bs, 12-lead) is not considered to be mdr reportable since the risk to the patient is low.On 27-jul-2021, the bwi product analysis lab received the complaint device for evaluation.On (b)(6) 2021, pal revealed that a visual inspection of the device found electrodes #14, #15 and #16 were misshaped and lifted.These findings were determined to be an mdr reportable malfunction.This event was originally considered non-reportable, however, bwi became aware of a reportable malfunction through product analysis on (b)(6) 2021 and reassessed it as mdr reportable.
 
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Brand Name
PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER
Type of Device
CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
Manufacturer (Section D)
BIOSENSE WEBSTER INC
31 technology drive, suite 200
irvine CA 92618
MDR Report Key12558747
MDR Text Key282417941
Report Number2029046-2021-01649
Device Sequence Number1
Product Code MTD
UDI-Device Identifier10846835012255
UDI-Public10846835012255
Combination Product (y/n)N
PMA/PMN Number
K123837
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial
Report Date 09/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/11/2024
Device Model NumberD128211
Device Catalogue NumberD128211
Device Lot Number30534999L
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/27/2021
Initial Date Manufacturer Received 09/14/2021
Initial Date FDA Received09/30/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
PENTARAY NAV ECO 7FR, D, 2-6-2
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