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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL BRAIDED SWARTZ¿ INTRODUCER, SL0¿. 8F, 63CM INTRODUCER, CATHETER

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ST. JUDE MEDICAL BRAIDED SWARTZ¿ INTRODUCER, SL0¿. 8F, 63CM INTRODUCER, CATHETER Back to Search Results
Model Number G407371
Device Problem Gas Leak (2946)
Patient Problems Air Embolism (1697); Paralysis (1997)
Event Date 02/18/2020
Event Type  Injury  
Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
 
Event Description
Related manufacturing ref: 3005334138-2020-00069. During the procedure, while inserting two introducers, air was aspirated and entered the coronary and cerebral arteries. The air was removed from the coronary artery, but paralysis developed temporarily. The paralysis later resolved and the patient was observed.
 
Event Description
Additional information was received indicating the patient has been re-hospitalized due to the paralysis.
 
Manufacturer Narrative
One 8f swartz braided introducer sheath and dilator were received for evaluation. The sheath passed pressure and aspiration leak testing with no anomalies observed. Microscopic inspection of the hemostasis seals revealed no anomalies. The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.
 
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Brand NameBRAIDED SWARTZ¿ INTRODUCER, SL0¿. 8F, 63CM
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 Key9750898
MDR Text Key180759534
Report Number3005334138-2020-00070
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K052644
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 04/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/31/2022
Device Model NumberG407371
Device Lot Number7067032
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/12/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/20/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/28/2019
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: 02/25/2020 Patient Sequence Number: 1
Treatment
SWARTZ BRAIDED INTRODUCER
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