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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. AGILIS¿ NXT STEERABLE INTRODUCER DUAL-REACH¿ 71 CM SHEATH, SMALL CURL, 8.5F INTRODUCER, CATHETER

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ST. JUDE MEDICAL, INC. AGILIS¿ NXT STEERABLE INTRODUCER DUAL-REACH¿ 71 CM SHEATH, SMALL CURL, 8.5F INTRODUCER, CATHETER Back to Search Results
Model Number 408309
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem ST Segment Elevation (2059)
Event Date 04/03/2019
Event Type  Injury  
Manufacturer Narrative
The investigation results will be provided in a subsequent submission.
 
Event Description
During an atrial fibrillation ablation procedure st segment elevation occurred. Following transseptal puncture st elevation was noted when the sheath was in the left atrium. There was no air visualized in the patient at this time and after a few minutes the patient returned to a normal rhythm with no intervention. The procedure was continued and completed with no adverse patient consequences.
 
Manufacturer Narrative
One 8. 5f agilis steerable introducer sheath was received for evaluation. The sheath passed pressure and aspiration leak testing with no anomalies observed. The cause of the reported st segment elevation could not be conclusively determined because a leak was not reproduced and there weren't any other anomalies found.
 
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Brand NameAGILIS¿ NXT STEERABLE INTRODUCER DUAL-REACH¿ 71 CM SHEATH, SMALL CURL, 8.5F
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.
14901 deveau place
minnetonka MN 55345
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.
14901 deveau place
minnetonka MN 55345
Manufacturer Contact
stephanie o' sullivan
5050 nathan lane north
plymouth, MN 55442
6517565400
MDR Report Key8533170
MDR Text Key142544199
Report Number2182269-2019-00047
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K061363
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number408309
Device Catalogue Number408309
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/08/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/17/2019
Was Device Evaluated by Manufacturer? Yes
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: 04/19/2019 Patient Sequence Number: 1
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