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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL ULTIMUM EV HEMOSTASIS INTRODUCER WITH TIP MARKER; INTRODUCER, CATHETER
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ST. JUDE MEDICAL ULTIMUM EV HEMOSTASIS INTRODUCER WITH TIP MARKER; INTRODUCER, CATHETER Back to Search Results
Model Number C407699
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code Blood Loss (2597)
Date of Event 04/24/2019
Type of Reportable Event Serious Injury
Additional 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 leak remains unknown.
 
Event or Problem Description
During the transcatheter aortic valve replacement procedure, a leak was noted from the hemostasis valve of the introducer.A blood transfusion was required to stabilize the patient.
 
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Brand Name
ULTIMUM EV HEMOSTASIS INTRODUCER WITH TIP MARKER
Common Device Name
INTRODUCER, CATHETER
Manufacturer (Section D)
ST. JUDE MEDICAL
5050 nathan lane north
plymouth MN 55442
MDR Report Key8605708
Report Number3005334138-2019-00240
Device Sequence Number13917678
Product Code DYB
UDI-Device Identifier05415067014382
UDI-Public05415067014382
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K140327
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 05/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date12/31/2020
Device Model NumberC407699
Device Lot Number6812503
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/24/2019
Initial Report FDA Received Date05/13/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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