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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETER

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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETER Back to Search Results
Model Number DS2C021
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Date 10/01/2019
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 reference number:2017865-2019-14938, 2017865-2019-14940, 2017865-2019-14942, 2017865-2019-14943, 2017865-2019-14944, 2017865-2019-14945. It was reported that the patient expired during an implant procedure. There is no known allegation from a health professional that suggests the death was related to the device. It was reported that the cause of death was due to respiratory issues during the procedure.

 
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Brand NameCPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETER
Type of DeviceCATHETER
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
Manufacturer Contact
elizabeth boltz
15900 valley view court
sylmar, CA 91342
8184932577
MDR Report Key9177016
MDR Text Key161917004
Report Number2017865-2019-14942
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK130257
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 10/10/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/10/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/31/2021
Device MODEL NumberDS2C021
Device LOT Number6517573
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 Received10/01/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/26/2018
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: 10/10/2019 Patient Sequence Number: 1
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