• 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, MEDIUM CURL, 8.5F; 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, MEDIUM CURL, 8.5F; INTRODUCER, CATHETER Back to Search Results
Model Number G408319
Device Problems Detachment Of Device Component (1104); Fluid/Blood Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/07/2018
Event Type  malfunction  
Event Description
During the procedure, the extension tube of the three way stopcock detached which resulted in blood leaking from the introducer.The introducer was replaced and the procedure was completed with no adverse consequences to the patient.
 
Manufacturer Narrative
The reported event of the sideport tubing becoming detached from the introducer, leading to a blood leak was confirmed.The sideport tubing had been detached from the hemostasis body.A leak was noted at this location due to the aforementioned damage.A leak was also noted at the hemostasis valve during functional testing.The cap was removed from the hemostasis hub and the hemostasis seals were microscopically inspected.Tearing, resulting in a hole, was noted in the proximal and distal seals.The cause of the torn seals and subsequent leak is consistent with damage during use.Further investigation revealed the sideport tubing was blocked by excessive adhesive proximal to the hemostasis hub, consistent with excess force required to flush the device and thus the reported sideport tubing detachment.The ifu states: do not remove dilator or catheter rapidly.Damage to the valve may occur, potentially compromising hemostasis.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
AGILIS¿ NXT STEERABLE INTRODUCER DUAL-REACH¿ 61 CM SHEATH, MEDIUM CURL, 8.5F
Type of Device
INTRODUCER, 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
MDR Report Key7642594
MDR Text Key112505741
Report Number3008452825-2018-00204
Device Sequence Number1
Product Code DYB
UDI-Device Identifier05414734206129
UDI-Public05414734206129
Combination Product (y/n)N
PMA/PMN Number
K061363
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 02/17/2019
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
Device Operator Health Professional
Device Expiration Date02/28/2021
Device Model NumberG408319
Device Catalogue NumberG408319
Device Lot Number6359102
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/24/2018
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/07/2018
Initial Date FDA Received06/27/2018
Supplement Dates Manufacturer Received02/12/2019
Supplement Dates FDA Received02/17/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
-
-