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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
Catalog Number D128208
Device Problems Contamination /Decontamination Problem (2895); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/24/2023
Event Type  malfunction  
Event Description
It was reported that a patient underwent a persistent atrial fibrillation (afib) ablation procedure with pentaray nav high-density mapping eco catheter and foreign particles were identified inside the packaging.It was reported that during the setup step, when opening the pentaray nav high-density mapping eco catheter from its sterile packaging, foreign particles were identified inside the packaging.Increased doubt about the sterility of the catheter occurred and the physician asked to change the catheter.They did not use the affected device on the patient.They immediately changed the pentaray nav high-density mapping eco catheter to another device.Additional information was received describing the foreign material to look like a small soft wire.Very thin and close to the pentaray knob.The foreign part was kept inside the packaging as it was visually detected by physician.
 
Manufacturer Narrative
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 a persistent atrial fibrillation (afib) ablation procedure with pentaray nav high-density mapping eco catheter and foreign particles were identified inside the packaging.It was reported that during the setup step, when opening the pentaray nav high-density mapping eco catheter from its sterile packaging, foreign particles were identified inside the packaging.Increased doubt about the sterility of the catheter occurred and the physician asked to change the catheter.They did not use the affected device on the patient.They immediately changed the pentaray nav high-density mapping eco catheter to another device.Device investigation details: a picture was received for evaluation following biosense webster's procedures.According to pictures provided by the customer, a foreign material was observed in packaging.The device has not been returned for analysis and a root cause is unable to be assigned based on the current evidence.If the device is received in the future, the product investigation will be performed and updated accordingly, and any action will be taken if necessary.A manufacturing record evaluation was performed, and no internal action related to the reported complaint condition were identified.The customer complaint was confirmed based on the picture received.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
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 Key18360962
MDR Text Key331191807
Report Number2029046-2023-03003
Device Sequence Number1
Product Code MTD
UDI-Device Identifier10846835012224
UDI-Public10846835012224
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K123837
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/19/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberD128208
Device Lot Number31082865L
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received02/09/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/07/2023
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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