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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 Fracture (1260)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/02/2019
Event Type  malfunction  
Manufacturer Narrative
Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(6).(b)(4).
 
Event Description
It was reported that a patient underwent an atrial fibrilation (afib) ablation procedure with a pentaray nav high-density mapping eco catheter and the tip became partially detached.It was reported that after the pentaray nav high-density mapping eco catheter was used successfully and withdrawn outside of patient, it looked good.But after a while, when physician finished the ablation and wanted to use pentaray nav high-density mapping eco catheter again, he found it fractured.A second catheter was used to complete the operation.There was no report on adverse event on patient.On 12/11/2019, biosense webster inc.Received additional information about the even and product.It was reported that there were no sharp or lifted rings.It is unknown if there was any resistance during insertion or removal.A st.Jude sheath was used.The customer provided images showing extensive damage to the tip assembly.The details of these event are not clear.It is most likely that the damage was inflicted outside of the patients body.However, since there is remote possibility that the damage was missed by the physician on initial inspection, with the available information this event will be conservatively reported.
 
Manufacturer Narrative
It was reported that a patient underwent an atrial fibrilation (afib) ablation procedure with a pentaray nav high-density mapping eco catheter and the tip became partially detached.It was reported that after the pentaray nav high-density mapping eco catheter was used successfully and withdrawn outside of patient, it looked good.But after a while, when physician finished the ablation and wanted to use pentaray nav high-density mapping eco catheter again, he found it fractured.A second catheter was used to complete the operation.There was no report on adverse event on patient.On 12/11/2019, biosense webster inc.Received additional information about the even and product.It was reported that there were no sharp or lifted rings.It is unknown if there was any resistance during insertion or removal.A st.Jude sheath was used.The customer provided images showing extensive damage to the tip assembly.The details of these event are not clear.It is most likely that the damage was inflicted outside of the patients body.Device evaluation details: the device evaluation has been completed.The returned device was inspected and wires are exposed in the shaft 3 inches from the tip.Again, during the second visual analysis wires were found exposed at 3 inches from the tip.The received device was inspected under the microscope and determined tip and the cables show evidence of being cut by some sharp object.A manufacturing record evaluation was performed and no internal actions related to the reported complaint were identified.The customer complaint has been confirmed.The root cause of the tip broken cannot be related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specification and procedures, it could be related to the handling of the device during the procedure, however, this cannot be conclusively determined.The customer had also provided photos of the reported issue.According to pictures provided, the tip was observed broken.Based on the pictures alone, the customer complaint had also been confirmed.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
On 1/6/2020, the complaint product was returned to biosense webster inc.¿s (bwi) product analysis lab (pal) for evaluation.Initial visual inspection found wires are exposed 3 inches from the tip.The findings were reviewed and determined to be mdr reportable malfunction since the integrity of the device is not maintained.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.Additionally, 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 Key9537071
MDR Text Key200063051
Report Number2029046-2019-04090
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,Followup
Report Date 12/05/2019
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 Date06/09/2022
Device Model NumberD128211
Device Catalogue NumberD128211
Device Lot Number30241002L
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/06/2020
Initial Date Manufacturer Received 12/05/2019
Initial Date FDA Received12/31/2019
Supplement Dates Manufacturer Received01/06/2020
02/05/2020
Supplement Dates FDA Received01/29/2020
02/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ST. JUDE SHEATH
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