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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. COOL POINT IRRIGATION PUMP; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
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ST. JUDE MEDICAL, INC. COOL POINT IRRIGATION PUMP; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER Back to Search Results
Model Number IBI-89003
Medical Device Problem Code Pressure Problem (3012)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 10/12/2021
Type of Reportable Event Malfunction
Event or Problem Description
During a premature ventricular contraction procedure, a pressure sensor error occurred and the pump stopped working.A replacement pump was borrowed from another facility which delayed the procedure.The procedure was completed with no adverse patient consequences.
 
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Brand Name
COOL POINT IRRIGATION PUMP
Common Device Name
CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.
2375 morse ave
irvine CA 92614
MDR Report Key12632893
Report Number2030404-2021-00072
Device Sequence Number4522539
Product Code OAD
UDI-Device Identifier05415067008985
UDI-Public05415067008985
Combination Product (Y/N)N
Initial Reporter StateUT
Initial Reporter CountryUS
PMA/510(K) Number
P060019
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 11/03/2021
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
Operator of Device Health Professional
Device Model NumberIBI-89003
Device Catalogue NumberIBI-89003
Device Lot Number7875314
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/01/2021
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 10/12/2021
Supplement Date Received by Manufacturer11/03/2021
Initial Report FDA Received Date10/14/2021
Supplement Report FDA Received Date11/03/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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