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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CPS DIRECT PL; CATHETER
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ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CPS DIRECT PL; CATHETER Back to Search Results
Model Number 410212
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Vascular Dissection (3160); Pericardial Effusion (3271)
Date of Event 09/05/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
 
Event or Problem Description
It was reported that the patient presented for a generator upgrade procedure.During the procedure, the sheath dissected the patient's ostium.The physician noted that the patient had abnormal anatomy.The procedure was abandoned.The sheath was discarded.A post-procedure echo revealed effusion.No further treatment was needed at the time and the patient was stable and will follow up once healed.
 
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Brand Name
CPS DIRECT PL
Common Device Name
CATHETER
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
645 almanor avenue
sunnyvale CA 94085
MDR Report Key9088091
Report Number2938836-2019-13758
Device Sequence Number16750373
Product Code DQY
UDI-Device Identifier05414734207072
UDI-Public05414734207072
Combination Product (Y/N)N
Initial Reporter CountryCA
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 09/19/2019
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
Operator of Device Health Professional
Device Expiration Date02/28/2022
Device Model Number410212
Device Lot Number6913945
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/05/2019
Initial Report FDA Received Date09/19/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age73 YR
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