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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOSENSE WEBSTER INC QDOT MICRO¿ CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

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BIOSENSE WEBSTER INC QDOT MICRO¿ CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION Back to Search Results
Catalog Number D139505
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Paralysis (1997)
Event Date 05/31/2023
Event Type  Injury  
Manufacturer Narrative
Device investigation details: 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 (mre) cannot be conducted because no lot number was provided by the customer.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.#: (b)(4).
 
Event Description
A patient underwent an atrial fibrillation (afib) ablation procedure involving a qdot micro¿ catheter and experienced difficulty breathing.The finding was detected after pulmonary vein isolation with qdot micro¿ catheter (with normal use and workflow).The physician observed a difference before and after the procedure, and a partial diaphragmatic paralysis was confirmed by a computed tomography (ct) scan.The reporter indicates this discovery was made "3 month after the procedure during a control to a pulmonologist.".
 
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Brand Name
QDOT MICRO¿ CATHETER
Type of Device
CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
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
kate karberg
31 technology dr
irvine, CA 92618
3035526892
MDR Report Key17946919
MDR Text Key325795838
Report Number2029046-2023-02337
Device Sequence Number1
Product Code OAE
UDI-Device Identifier10846835016758
UDI-Public10846835016758
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
P210027
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 10/16/2023
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 Catalogue NumberD139505
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/22/2023
Initial Date FDA Received10/16/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age71 YR
Patient SexFemale
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