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U.S. Department of Health and Human Services

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

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BIOSENSE WEBSTER INC PENTARAY NAV ECO; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY Back to Search Results
Model Number D128208
Device Problems Material Deformation (2976); Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/01/2022
Event Type  malfunction  
Manufacturer Narrative
The product investigation was completed.Device evaluation details: a picture showing catheter packaging and device tip was received for analysis, the photo does not provide sufficient information related to the reported event and therefore no result can be obtained from it.Visual analysis of the returned device revealed that the spline b was found bent, the electrode was found lifted, and no residues of pu (polyurethane) on the edge were observed the instructions for use contain the following recommendations: do not use excessive force to advance or withdraw the catheter through the guiding sheath when resistance is encountered.A manufacturing record evaluation was performed for the finished device 30693822l number, and no internal action was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
 
Event Description
A patient underwent an ablation procedure with a pentaray nav eco for which biosense webster¿s product analysis lab identified that spline b was found bent, the electrode was found lifted, and no residues of pu (polyurethane) on the edge were observed.The finding was identified on (b)(6) 2022.It was initially reported by the customer that during the procedure electrode 11 was physically damaged and the spline c was partially folded.The physician acknowledged that he pushed with intensity during the introduction into the long sheath.No patient consequences were reported.Bent spline is not mdr-reportable.Electrode damage is mdr-reportable.
 
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Brand Name
PENTARAY NAV ECO
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
michelleann garcia
31 technology dr
irvine, CA 92618
646591-798
MDR Report Key15273388
MDR Text Key305498840
Report Number2029046-2022-01956
Device Sequence Number1
Product Code MTD
UDI-Device Identifier10846835012224
UDI-Public10846835012224
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K123837
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 08/22/2022
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 Model NumberD128208
Device Catalogue NumberD128208
Device Lot Number30693822L
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/29/2022
Initial Date Manufacturer Received 07/29/2022
Initial Date FDA Received08/23/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/21/2021
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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