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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Occlusion (1984); Stenosis (2263); Vascular Dissection (3160)
Event Date 07/26/2018
Event Type  Injury  
Event Description
After a successfull portico implant, the ultimum 19f was removed. An angio control has showed a complete occlusion of the left cfa. A tea and an artery reconstruction with a biocompatible tissue was performed. An angio post intervention showed a left cfa stenosis: a pta was performed with a 7 mm balloon with good final result.
 
Manufacturer Narrative
Additional information was received that this event was not related to the ultimum introducer and is therefore not reportable to the ultimum introducer.
 
Event Description
On (b)(6) 2018, a 27 mm portico valve was implanted with a 19 fr portico delivery system. After a successful portico implant, the ultimum ev hemostasis introducer was removed. An angio control showed complete occlusion of the left cfa. A tea and an artery reconstruction with a biocompatible tissue was performed. An angio post intervention showed a left cfa stenosis and a pta was performed with a 7 mm balloon with good final result. The patient is reported to be recovering. The operators and the vascular surgeon believes the closure systems (2 proglide) has moved a huge calcification, next to the femoral bifurcation, that has occluded the cfa. On (b)(6), the physician indicated the cause of the occlusion was a dissection that was created during use of the portico delivery system or ultimum ev hemostasis introducer.
 
Manufacturer Narrative
An event of a vessel occlusion and dissection was reported. 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 incident could not be conclusively determined.
 
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Brand NameULTIMUM EV HEMOSTASIS INTRODUCER WITH TIP MARKER
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
elizabeth boltz
5050 nathan lane north
plymouth, MN 55442
6517565400
MDR Report Key7774698
MDR Text Key116852100
Report Number3005334138-2018-00258
Device Sequence Number1
Product Code DYB
UDI-Device Identifier05415067014382
UDI-Public05415067014382
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K140327
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 10/25/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/29/2020
Device Model NumberC407699
Device Catalogue NumberC407698
Device Lot Number6381038
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/25/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/27/2018
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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