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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Vasoconstriction (2126)
Event Date 07/03/2020
Event Type  Injury  
Manufacturer Narrative
Investigation is in progress, once completed a supplemental will be submitted.(b)(4).
 
Event Description
It was reported that a patient underwent atrial fibrillation (afib) ablation procedure with pentaray nav high-density mapping eco catheter and suffered st-segment elevation, hypotension and requiring no intervention.After transseptal (bb), mapping was conducted for left atrium (la) by pentaray nav high-density mapping eco catheter, after that, pulmonary vein isolation (pvi) was carried out.After pvi, atrial tachycardia re-occurred and la and right atrium (ra) were mapped using the pentaray nav high-density mapping eco catheter.At that point wide qrs, hypotension, st elevation, and tachycardia appeared.An emergency coronary angiography (cag) was performed and no abnormalities such as stenosis were confirmed, so it was diagnosed that spasm had occurred due to some factor.After mapping, after approximately 2 hours of use when the catheter was removed it was noticed that the irrigation was not working.It has been confirmed that the catheter was set-up as usual before the catheter is placed inside the cardiac cavity.The staff attempted to flush the catheter with a syringe without success.The issue was resolved by changing the catheter to another one.When it was discovered that pentaray nav high-density mapping eco catheter had not been irrigation in the latter half of the procedure, the physician commented that there might be some causal relationship between poor drip and spasm.After surgery, there is no particular problem with the patient's condition.The caller does not think there is causal relationship to the device.The electrocardiogram st segment elevation, hypotension, tachycardia are symptoms of arterial spasm thus only the ¿arterial spasm¿ shall be coded.Since emergency cag was required, this event will be considered serious injury.There was no report of extended hospitalization.The physician¿s causality opinion was not provided.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.Should more information become available in the future; the reportability decision will be reassessed.
 
Manufacturer Narrative
It was reported that a patient underwent atrial fibrillation (afib) ablation procedure with pentaray nav high-density mapping eco catheter and suffered st-segment elevation, hypotension and requiring no intervention.After transseptal (bb), mapping was conducted for left atrium (la) by pentaray nav high-density mapping eco catheter, after that, pulmonary vein isolation (pvi) was carried out.After pvi, atrial tachycardia re-occurred and la and right atrium (ra) were mapped using the pentaray nav high-density mapping eco catheter.At that point wide qrs, hypotension, st elevation, and tachycardia appeared.An emergency coronary angiography (cag) was performed and no abnormalities such as stenosis were confirmed, so it was diagnosed that spasm had occurred due to some factor.After mapping, after approximately 2 hours of use when the catheter was removed it was noticed that the irrigation was not working.It has been confirmed that the catheter was set-up as usual before the catheter is placed inside the cardiac cavity.The staff attempted to flush the catheter with a syringe without success.The issue was resolved by changing the catheter to another one.When it was discovered that pentaray nav high-density mapping eco catheter had not been irrigation in the latter half of the procedure, the physician commented that there might be some causal relationship between poor drip and spasm.After surgery, there is no particular problem with the patient's condition.The caller does not think there is causal relationship to the device.Correction: it was noticed the following information was inadvertently omitted from the event description reported in the 3500a initial medwatch report: ¿the customer¿s reported irrigation issue is considered not mdr reportable since the issue is highly detectable by the physician and the potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.¿ device evaluation details: the device evaluation has been completed.On(b)(6)2020 , the complaint product was returned to biosense webster inc.¿s (bwi) product analysis lab (pal) for evaluation.Upon receipt, the catheter was visually inspected and it was found in normal conditions.The magnetic, electrical and deflection features were tested and no issues were 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 near the electrode #22.A manufacturing record evaluation was performed and no internal actions related to the reported complaint were identified.The customer complaint regarding irrigation has been verified.The root cause of the adverse event remains unknown.The root cause of the irrigation tube folded cannot be determined; this failure does not represent any patient consequence.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# pc-000725048.
 
Manufacturer Narrative
On 9/13/2020, biosense webster inc.Received additional information about the patient and the event.It was reported the patient in this case was male.This adverse event was discovered post use of biosense webster products.The physician¿s opinion is that the cause of this adverse event is procedure.The patient¿s condition has improved.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 Key10299855
MDR Text Key200267564
Report Number2029046-2020-00901
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 08/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date03/25/2023
Device Model NumberD128211
Device Catalogue NumberD128211
Device Lot Number30379535L
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/03/2020
Date Manufacturer Received09/13/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
UNKNOWN SYRINGE
Patient Outcome(s) Other;
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