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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOSENSE WEBSTER INC SMARTABLATE¿ IRRIGATION TUBING SET; CARDIAC ABLATION PERCUTANEOUS CATHETER
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BIOSENSE WEBSTER INC SMARTABLATE¿ IRRIGATION TUBING SET; CARDIAC ABLATION PERCUTANEOUS CATHETER Back to Search Results
Catalog Number SAT001
Device Problems Contamination /Decontamination Problem (2895); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2023
Event Type  malfunction  
Event Description
It was reported that a patient underwent a cardiac ablation procedure with a smartablate¿ irrigation tubing set and hair in sterile package was observed.It was reported that there was hair in sterile package.There was no patient consequence.Additional information was requested; however, no further information was provided.
 
Manufacturer Narrative
B3.Date of event: the event date is unknown.As a result, the 1st day of the year has been entered as the event date.E 1.Initial reporter phone: (b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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.Manufacturer's reference number: (b)(4).
 
Manufacturer Narrative
It was reported that a patient underwent a cardiac ablation procedure with a smartablate¿ irrigation tubing set and hair in sterile package was observed.It was reported that there was hair in sterile package.There was no patient consequence.Additional information was received on 27-jul-2023.It was reported that the device was not used on the patient.The packaging (tray, box, labels) as well as the catheter and the foreign material were discarded except the sterile bag.Device investigation details: the device investigation has been completed which included performing a manufacturing record evaluation (mre).The manufacturing record evaluation performed for the finished device with lot number ac8281935 identified no internal actions related to the reported complaint condition.Additionally, the manufactured date has been provided.Therefore, field h4.Device manufacture date has been populated.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.However, if the product is received at a later date, the investigation will be updated as applicable.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.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 08-feb-2024, the biosense webster, inc.Product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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
SMARTABLATE¿ IRRIGATION TUBING SET
Type of Device
CARDIAC ABLATION PERCUTANEOUS CATHETER
Manufacturer (Section D)
BIOSENSE WEBSTER INC
31 technology drive, suite 200
irvine CA 92618
Manufacturer (Section G)
LAKE REGION MEDICAL
31-c butterfield trail
el paso TX 79906 0000
Manufacturer Contact
kate karberg
31 technology dr
irvine, CA 92618
3035526892
MDR Report Key17392740
MDR Text Key319928535
Report Number2029046-2023-01583
Device Sequence Number1
Product Code LPB
UDI-Device Identifier10846835009743
UDI-Public10846835009743
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P990017/S17
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 03/01/2024
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 Date04/30/2024
Device Catalogue NumberSAT001
Device Lot NumberAC8281935
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/26/2023
Initial Date FDA Received07/25/2023
Supplement Dates Manufacturer Received07/27/2023
02/08/2024
Supplement Dates FDA Received08/23/2023
03/01/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/04/2023
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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