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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL PEEL-AWAY INTRODUCER 14CM SHEATH INTRODUCER KIT, 6F INTRODUCER, CATHETER

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ST. JUDE MEDICAL PEEL-AWAY INTRODUCER 14CM SHEATH INTRODUCER KIT, 6F INTRODUCER, CATHETER Back to Search Results
Model Number 405104
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pneumothorax (2012)
Event Date 09/30/2020
Event Type  Injury  
Manufacturer Narrative
The results, method and conclusion codes along with investigation results will be provided in the final report.
 
Event Description
During an lv implant procedure, a pneumothorax occurred. Access was gained by a left subclavian vein puncture for lead implant. During subclavian puncture, the patient complained of slight chest pain and a pneumothorax occurred. There were no clinical consequences for the patient at the time of the pneumothorax, and the procedure was successfully completed. However, following the procedure, a drainage canula was applied for one day in order to resolve the pneumothorax. The patient is stable and in good condition. The cause of the pneumothorax is unknown. There were no performance issues with any abbott devices.
 
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Brand NamePEEL-AWAY INTRODUCER 14CM SHEATH INTRODUCER KIT, 6F
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
ST. JUDE MEDICAL
5050 nathan lane north
plymouth MN 55442
Manufacturer (Section G)
ST. JUDE MEDICAL
5050 nathan lane north
plymouth MN 55442
Manufacturer Contact
stephanie o' sullivan
5050 nathan lane north
plymouth, MN 55442
6517565400
MDR Report Key10744675
MDR Text Key213430271
Report Number3005334138-2020-00504
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K894431
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number405104
Device Catalogue Number405104
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 Received11/10/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

Patient Treatment Data
Date Received: 10/27/2020 Patient Sequence Number: 1
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