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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
Device Problems Fluid Leak (1250); Split (2537)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/07/2018
Event Type  malfunction  
Event Description
When the ultimum ev hemostasis introducer was used, blood leaked out of the hemostatic valve of the sheath. After the removal of the inner dilator, the tip was found to be split. The procedure was completed without the use of another ultimum ev hemostasis introducer. The patient weight is not available.
 
Manufacturer Narrative
The reported event of a leak could not be confirmed; however, the reported event of a split dilator distal tip was confirmed. Visual inspection confirmed that the dilator tip was split. Functional testing revealed that the sheath passed pressure and aspiration leak testing with no anomalies observed. However, the cap was removed from the hemostasis hub and microscopic inspection revealed a tear on the visible surface on the proximal side of the hemostasis seal. The device history record was reviewed to ensure that each manufacturing and inspection operation was performed. The cause of the reported leak remains unknown as the event could not be confirmed. The cause of the torn seal and split dilator is consistent with damage during use. Additional information revealed the initial mdr for this event was reported under the incorrect mfr report # and manufacturing site. Corrected manufacturing site information has been provided. (b)(4). The ultimum hemostasis introducer sheath instructions for use (ifu) states damage to the valve assembly may occur if the inner catheter is withdrawn rapidly. The ultimum hemostasis introducer sheath instruction for use (ifu) states that the user should advance the dilator/sheath assembly with a twisting motion to avoid damage to the sheath or vessel. The ultimum hemostasis introducer sheath instruction for use (ifu) cautions that individual patient anatomy and physician technique may require procedural variations.
 
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Brand NameULTIMUM EV HEMOSTASIS INTRODUCER WITH TIP MARKER
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
ST. JUDE MEDICAL
14901 deveau place
minnetonka MN 55345 2126
MDR Report Key7652936
MDR Text Key112850905
Report Number2182269-2018-00076
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
PMA/PMN Number
K140327
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 07/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2019
Device Model NumberC407699
Device Catalogue NumberC407698
Device Lot Number6194384
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/13/2018
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/13/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 06/29/2018 Patient Sequence Number: 1
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