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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOSENSE WEBSTER INC PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE INTRODUCER, CATHETER

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BIOSENSE WEBSTER INC PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE INTRODUCER, CATHETER Back to Search Results
Model Number 301803MS
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/08/2022
Event Type  malfunction  
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Brand NamePREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE
Type of DeviceINTRODUCER, CATHETER
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
michelleann garcia
31 technology dr
irvine, CA 92618
646591-798
MDR Report Key15317748
Report Number2029046-2022-02039
Device Sequence Number1
Product Code DYB
UDI-Device Identifier10846835000030
UDI-Public10846835000030
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K982740
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/25/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/30/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number301803MS
Device Catalogue Number301803MS
Device Lot Number18079353
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received10/05/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/25/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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