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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 Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 07/25/2018
Type of Reportable Event Serious Injury
Event or Problem Description
After successful implantation of the ultimum ev hemostasis introducer, the ultimum sheath was removed from the art.Femoralis.The rinse arm of the sheath had detached itself from the lock.
 
Additional Manufacturer Narrative
The reported event of detached extension tube was confirmed.The extension tubing had detached from the sideport of the hemostasis body due to an inadequate solvent coating length on the extension tubing.
 
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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 Key7774708
Report Number3005334138-2018-00260
Device Sequence Number16396917
Product Code DYB
UDI-Device Identifier05415067014382
UDI-Public05415067014382
Combination Product (Y/N)N
Initial Reporter CountryGM
PMA/510(K) Number
K140327
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 11/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date02/29/2020
Device Model NumberC407699
Device Catalogue NumberC407698
Device Lot Number6381038
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 07/25/2018
Supplement Date Received by Manufacturer11/27/2018
Initial Report FDA Received Date08/10/2018
Supplement Report FDA Received Date11/28/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age88 YR
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