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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. VIZIGO INTRODUCER, CATHETER

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BIOSENSE WEBSTER INC. VIZIGO INTRODUCER, CATHETER Back to Search Results
Model Number D138502
Device Problem Failure to Advance (2524)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/23/2021
Event Type  No Answer Provided  
Event Description
During preparation of the sheath, the dilator would not pass through the sheath. The sheath was removed and replaced with a new sheath. There was no harm to the patient.
 
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Brand NameVIZIGO
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
BIOSENSE WEBSTER INC.
15715 arrow hwy
irwindale CA 91706
MDR Report Key13117589
MDR Text Key282972666
Report Number13117589
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 12/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Model NumberD138502
Device Catalogue NumberD138502
Device Lot Number1814
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/10/2021
Event Location Hospital
Date Report to Manufacturer12/30/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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