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U.S. Department of Health and Human Services

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

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ST. JUDE MEDICAL AGILIS NXT STEERABLE INTRODUCER DUAL-REACH 71 CM SHEATH, SMALL CURL, 8.5F; INTRODUCER, CATHETER Back to Search Results
Model Number 408309
Device Problems Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/18/2020
Event Type  malfunction  
Manufacturer Narrative
One 8.5f agilis steerable introducer sheath was received for evaluation.The sheath was bent in multiple locations and had been cut in half.Functional testing was not possible due to the aforementioned damage.The distal end of the introducer was dissected and the pull wires were still connected to the pull ring; however, the sheath handle was opened, and the pull wire windows were noted to be torn, consistent with the reported deflection issue.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the pull wire window damage is consistent with damage during use.
 
Event Description
This report is to advise of an event observed during analysis confirming a pull wire window tear within the introducer handle, consistent with the reported deflection and removal difficulties.
 
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Brand Name
AGILIS NXT STEERABLE INTRODUCER DUAL-REACH 71 CM SHEATH, SMALL 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
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
stephanie o' sullivan
5050 nathan lane north
plymouth, MN 55442
6517565400
MDR Report Key10738496
MDR Text Key213194315
Report Number3008452825-2020-00543
Device Sequence Number1
Product Code DYB
UDI-Device Identifier05414734206099
UDI-Public05414734206099
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K061363
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 10/26/2020
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 Date08/31/2022
Device Model Number408309
Device Catalogue Number408309
Device Lot Number7162986
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/07/2020
Initial Date FDA Received10/26/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/04/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age68 YR
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