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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. CPS DIRECT SL II (SLITTABLE) OUTER GUIDE CATHETER
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ST. JUDE MEDICAL, INC. CPS DIRECT SL II (SLITTABLE) OUTER GUIDE CATHETER Back to Search Results
Model Number DS2C003
Device Problems Difficult to Insert (1316); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Pericardial Effusion (3271)
Event Date 10/23/2018
Event Type  Death  
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 Description
Related manufacturer report number: 2017865-2018-16470. During an implant procedure, there were insertion difficulties noted while inserting the left ventricular (lv) lead into a lateral vein and there were high pacing thresholds and phrenic nerve stimulation. The lead was being repositioned when the patient became hypotensive. An echocardiogram was performed, revealing a pericardial effusion which was treated with a pericardiocentesis. The lv lead was removed, the implant procedure was abandoned, and a cardiothoracic surgeon performed a thoracotomy to resolve the effusion. It was suspected that the decrease in blood pressure was due to the anticoagulant therapy of the patient. The patient was transferred to the intensive care unit and is currently stable. There were no performance issues noted with any abbott devices during the procedure.
 
Event Description
Additional information was received indicating that the cardiac perforation was due to a non-abbott device.
 
Event Description
Additional information was received indicating that the patient expired. The primary cause of death was septic shock and there was no allegation that any abbott device caused or contributed to the patient's death.
 
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Brand NameCPS DIRECT SL II (SLITTABLE) OUTER GUIDE CATHETER
Type of DeviceCATHETER
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.
15900 valley view court
sylmar CA 91342
Manufacturer Contact
robert greenleaf
15900 valley view court
sylmar, CA 91342
8184932577
MDR Report Key8048151
MDR Text Key126452689
Report Number2017865-2018-16677
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K092075
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2021
Device Model NumberDS2C003
Device Lot Number6457402
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/12/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/16/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/07/2018 Patient Sequence Number: 1
Treatment
1456Q/86, (B)(4)
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