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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL PEEL-AWAY INTRODUCER 14 CM SHEATH INTRODUCER KIT, 8F INTRODUCER, CATHETER

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ST. JUDE MEDICAL PEEL-AWAY INTRODUCER 14 CM SHEATH INTRODUCER KIT, 8F INTRODUCER, CATHETER Back to Search Results
Model Number 405116
Device Problems Fracture (1260); Difficult to Insert (1316)
Patient Problems Hematoma (1884); Pneumothorax (2012)
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 implantable cardioverter-defibrillator procedure, the sheath peeled at the distal end while being inserted. Following the procedure, a pneumothorax and a compartment hematoma were noted.
 
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Brand NamePEEL-AWAY INTRODUCER 14 CM SHEATH INTRODUCER KIT, 8F
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 Key11019261
MDR Text Key221752878
Report Number3005334138-2020-00608
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeFR
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,Followup,Followup
Report Date 02/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number405116
Device Catalogue Number405112
Device Lot Number7258781
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/19/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/18/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/05/2019
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: 12/16/2020 Patient Sequence Number: 1
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