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U.S. Department of Health and Human Services

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

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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CPS DIRECT PL CATHETER Back to Search Results
Model Number 410213
Device Problems Component Missing (2306); Device Operates Differently Than Expected (2913)
Patient Problem Hemostasis (1895)
Event Date 09/15/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that during implant procedure, the peelable catheter did not seem tight and was missing a silicon sealing ring. The patient experienced excessive bleeding. The catheter was replaced. The patient experienced no adverse consequences.

 
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Brand NameCPS DIRECT PL
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
jaime chavez
15900 valley view court
sylmar, CA 91342
8184934022
MDR Report Key6041764
MDR Text Key57880944
Report Number2017865-2016-06661
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUK
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 09/15/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/19/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/31/2019
Device MODEL Number410213
Device LOT Number5376578
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/15/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/03/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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