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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 Problem Coagulation in Device or Device Ingredient (1096)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/27/2020
Event Type  malfunction  
Manufacturer Narrative
If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
 
Event Description
It was reported that a patient underwent an ablation procedure with a pentaray nav high-density mapping eco catheter and a clot issue occurred.It was reported by the customer that there was a clot on the pentaray nav high-density mapping eco catheter during a cardiac ablation procedure.The procedure was not delayed due to the issue experienced.It is unknown how the issue was resolved, however it was reported that the procedure was completed successfully.There were no patient consequences reported.Multiple attempts were made to obtain further details regarding this event; however, no response was received.Should more information become available, it will be reviewed and processed accordingly.
 
Manufacturer Narrative
It was reported that a patient underwent an ablation procedure with a pentaray nav high-density mapping eco catheter and a clot issue occurred.It was reported by the customer that there was a clot on the pentaray nav high-density mapping eco catheter during a cardiac ablation procedure.The procedure was not delayed due to the issue experienced.It is unknown how the issue was resolved, however it was reported that the procedure was completed successfully.There were no patient consequences reported.On (b)(6) 2020, the complaint product was returned to biosense webster inc.¿s (bwi) product analysis lab (pal) for evaluation.Initial visual analysis observed there was no visual damage or anomalies.Device evaluation details: the device evaluation has been completed.The device was visually inspected, and it was found in good normal conditions.Electrical test was performed on the catheter and it was found within specifications.No electrical malfunction was observed.Then per the reported event, an irrigation test was performed, and the catheter failed.The catheter was dissected, and it was found that the irrigation tubing was folded in tip area.A manufacturing record evaluation was performed for the finished device, and no internal actions related to the reported complaint condition were identified.The customer complaint cannot be confirmed since no evidence of clot residue was observed on the catheter; however, the root cause of the clot reported by the customer could be related to the usage of the device during the procedure but this cannot be conclusively determined.The root cause of the irrigation tube folded cannot be determined.All units are inspected prior leaving the facility and mre verified that this complaint unit was in good condition.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
PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER
Type of Device
CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
Manufacturer (Section D)
BIOSENSE WEBSTER INC.
33 technology drive
irvine CA 92618
MDR Report Key10172377
MDR Text Key195713780
Report Number2029046-2020-00731
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,Followup
Report Date 05/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/05/2023
Device Model NumberD128211
Device Catalogue NumberD128211
Device Lot Number30346993L
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/20/2020
Date Manufacturer Received07/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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