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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CPS DIRECT; CATHETER, PERCUTANEOUS
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CPS DIRECT; CATHETER, PERCUTANEOUS Back to Search Results
Model Number DS2C021
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Cardiac Perforation (2513)
Date of Event 10/08/2020
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 a catheter punctured a patient's heart during a implantable cardioverter defibrillator upgrade procedure.The puncture was discovered by a fluoroscopy.The patient was hemodynamically stable.Catheter was removed safely.The upgrade procedure was abandoned.Patient was stable after the procedure.
 
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Brand Name
CPS DIRECT
Common Device Name
CATHETER, PERCUTANEOUS
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
MDR Report Key10731292
Report Number2017865-2020-16089
Device Sequence Number3313040
Product Code DQY
UDI-Device Identifier05415067004208
UDI-Public05415067004208
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K130257
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) 10/23/2020
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 Model NumberDS2C021
Device Catalogue NumberDS2C021
Device Lot Number7464994
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 10/08/2020
Initial Report FDA Received Date10/23/2020
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;
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