• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL AGILIS¿ NXT STEERABLE INTRODUCER DUAL-REACH¿ 61 CM SHEATH, SMALL CURL DUAL-REACH INTRODUCER, CATHETER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ST. JUDE MEDICAL AGILIS¿ NXT STEERABLE INTRODUCER DUAL-REACH¿ 61 CM SHEATH, SMALL CURL DUAL-REACH INTRODUCER, CATHETER Back to Search Results
Model Number G408318
Device Problem Material Twisted/Bent (2981)
Patient Problem Vascular Dissection (3160)
Event Date 07/06/2022
Event Type  Injury  
Event Description
During the atrial fibrillation procedure, a blood vessel was perforated. The sheath guidewire was inserted without noticing that was bent after vein puncture and it made a hole in a blood vessel and bleeding occurred. A cardiovascular surgery was performed to close the hole. The introducer was replaced and the procedure was completed with no adverse consequences to the patient.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameAGILIS¿ NXT STEERABLE INTRODUCER DUAL-REACH¿ 61 CM SHEATH, SMALL CURL DUAL-REACH
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
ST. JUDE MEDICAL
parque industrial, zona franca coyol s.a.
edificio #44b, calle 0, avenida 2, coyol
alajuela, costa rica 1897- 4050
CS 1897-4050
Manufacturer (Section G)
ST. JUDE MEDICAL
parque industrial, zona franca coyol s.a.
edificio #44b, calle 0, avenida 2, coyol
alajuela, costa rica 1897- 4050
CS 1897-4050
Manufacturer Contact
janna parks
5050 nathan lane north
plymouth, MN 55442
6517565400
MDR Report Key15017568
MDR Text Key295950638
Report Number3008452825-2022-00518
Device Sequence Number1
Product Code DYB
UDI-Device Identifier05414734206112
UDI-Public05414734206112
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K061363
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberG408318
Device Catalogue NumberG408318
Device Lot Number8221068
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received08/15/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/12/2021
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: 07/14/2022 Patient Sequence Number: 1
-
-