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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOSENSE WEBSTER INC WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

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BIOSENSE WEBSTER INC WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING Back to Search Results
Model Number D135303
Device Problem Patient Device Interaction Problem (4001)
Patient Problems Hemorrhage/Bleeding (1888); Ventricular Fibrillation (2130); Heart Block (4444)
Event Date 02/17/2022
Event Type  Injury  
Manufacturer Narrative
Initial reporter phone: (b)(6).The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30691787m number, and no internal action related to the complaint was found during the review.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).
 
Event Description
It was reported that a male patient underwent a ventricular tachycardia (vt) ablation procedure with a webster cs catheter with auto id technology and suffered ventricular fibrillation requiring surgical intervention.It was reported that at a vt procedure, vt persisted (hemodynamics did not stabilize), so burst pacing was performed through a catheter placed in the heart, but the vt did not stop.The vt shifted to ventricular fibrillation (vf), and it was stopped by external cardioversion, but blood pressure did not increase.Finally, an impella device, a pump catheter for auxiliary circulation was placed intracardially to stabilize hemodynamics.The procedure was then completed.According to the physician's comment, the patient had a background that ¿the original cardiac function was not good.¿ ablation was not done, so there was no causal relationship with the product.The procedure caused massive bleeding and the product could not be collected.The complaint product will not be returned for analysis.The soundstar eco catheter lot number is e8350469.This adverse event was discovered during use of biosense webster products.The physician¿s opinion on the cause of this adverse event is that it was patient condition related.The patient outcome of the adverse event was reported as improved.Follow up has been requested to clarify why ¿heart block¿ was written in the initial report, as no further details about heart block was provided.Until clarification is received, heart block will not be coded as event description provided described ventricular fibrillation and not heart block.Once clarification is received, this information will be reassessed accordingly.
 
Manufacturer Narrative
Additional information was received.It was reported that the patient is 46 years old.Therefore, a 2.Patient age at the time of event and a 2.Age unit have been updated.The physician¿s name has been provided.Therefore, e 1.Initial reporter title, e 1.Initial reporter first name, e1.Initial reporter last name and h 2.Health professional? have been updated.The patient required extended hospitalization because of the adverse event but details are unknown.Therefore, b 2.Is hospitalization initial/prolonged and h 6.Health effect - impact code have been updated.Clarification has been received from the bwi representative.Heart block was being reported in addition to ventricular fibrillation (vfib).Blood pressure did not rise after vfib was stopped, and the physician judged it as heart block.An impella was implanted against the heart block.The h6.Health effect - clinical code has been updated to include heart block (e060106).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
 
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Brand Name
WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY
Type of Device
CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
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
gabriel alfageme
31 technology dr
irvine, CA 92618
9497898687
MDR Report Key13817616
MDR Text Key290467680
Report Number2029046-2022-00570
Device Sequence Number1
Product Code DRF
UDI-Device Identifier10846835009972
UDI-Public10846835009972
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K080425
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberD135303
Device Catalogue NumberD135303
Device Lot Number30691787M
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/17/2022
Initial Date FDA Received03/19/2022
Supplement Dates Manufacturer Received04/12/2022
Supplement Dates FDA Received05/10/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
SOUNDSTAR ECO SMS 8F CATHETER; UNK IMPELLA HEART PUMP
Patient Outcome(s) Hospitalization; Required Intervention; Life Threatening;
Patient Age46 YR
Patient SexMale
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