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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 410211
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hemostasis (1895)
Event Date 03/03/2017
Event Type  Injury  
Event Description

It was reported that during an implant procedure, the implanting sheath had caused the implant site to ooze and bleeding at the junction of the hemostatic valve. The physician attempted to suture the pocket to resolve the issue but bleeding continued. The sheath was removed and replaced successfully. The patient was in stable condition.

 
Manufacturer Narrative

Full analysis could not be performed due to damage found on the returned product. All damage found was sustained during procedure.

 
Manufacturer Narrative

Correction on expiration date and manufacturing date fields.

 
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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
denise johnson
5050 nathan lane north
plymouth, MN 55442
6517564470
MDR Report Key6487263
MDR Text Key72616811
Report Number2017865-2017-02229
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeCH
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 08/24/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/12/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/31/2019
Device MODEL Number410211
Device LOT Number5458602
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/24/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/23/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/11/2016
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: 04/12/2017 Patient Sequence Number: 1
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