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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL PEEL-AWAY INTRODUCER, 7F TW, DI-LOCK, 14CM INTRODUCER, CATHETER

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ST. JUDE MEDICAL PEEL-AWAY INTRODUCER, 7F TW, DI-LOCK, 14CM INTRODUCER, CATHETER Back to Search Results
Model Number 405154
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pneumothorax (2012)
Event Date 02/25/2019
Event Type  Injury  
Event Description
During the implantation procedure, a pneumothorax occurred. When puncturing the subclavien vein in preparation for probe insertion for the crt-d system, a pneumothorax occurred. A pleural drainage was administered to stabilize the patient.
 
Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis. The device history record was reviewed to ensure that each manufacturing and inspection operation was performed. Based on the information received, the cause of the reported pneumothorax could not be conclusively determined.
 
Event Description
There were no performance issues with any abbott device.
 
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Brand NamePEEL-AWAY INTRODUCER, 7F TW, DI-LOCK, 14CM
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
ST. JUDE MEDICAL
5050 nathan lane north
plymouth MN 55442
MDR Report Key8429954
MDR Text Key139116955
Report Number3005334138-2019-00148
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
PMA/PMN Number
K791129
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 03/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2021
Device Model Number405154
Device Catalogue Number405154
Device Lot Number6673994
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/19/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 03/18/2019 Patient Sequence Number: 1
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