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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH TRANSSEPTAL GUIDING INTRODUCER SWARTZ SL TRANSSEPTAL SERIES, SL1 8.; INTRODUCER, CATHETER
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ST. JUDE MEDICAL FAST-CATH TRANSSEPTAL GUIDING INTRODUCER SWARTZ SL TRANSSEPTAL SERIES, SL1 8.; INTRODUCER, CATHETER Back to Search Results
Model Number 406849
Device Problems Fluid/Blood Leak (1250); Fracture (1260)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/07/2020
Event Type  malfunction  
Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
 
Event Description
During an ablation procedure for atrial fibrillation, there was a crack on the tip of the outer sheath and blood leaked out of the introducer.The brk needle was inserted into the hemostasis valve prior to the reported leak.The device was replaced and the procedure was completed with no adverse consequences to the patient.
 
Manufacturer Narrative
One 8.5f fast-cath introducer sheath was received for evaluation.The dilator was also received.A leak was noted at the hemostasis valve during functional testing.The cap was removed from the hemostasis hub and the hemostasis seal was microscopically inspected.Tearing, resulting in a hole, was noted in slit of the seal.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the torn seal and subsequent leak is consistent with damage during use.The ifu states damage to the valve assembly may occur if inner catheter is withdrawn rapidly.
 
Manufacturer Narrative
One 8.5f fast-cath introducer sheath was received for evaluation.The dilator was also received.A leak was noted at the hemostasis valve during functional testing.The cap was removed from the hemostasis hub and the hemostasis seal was microscopically inspected.Tearing, resulting in a hole, was noted in slit of the seal.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the torn seal and subsequent leak is consistent with damage during use.
 
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Brand Name
FAST-CATH TRANSSEPTAL GUIDING INTRODUCER SWARTZ SL TRANSSEPTAL SERIES, SL1 8.
Type of Device
INTRODUCER, CATHETER
Manufacturer (Section D)
ST. JUDE MEDICAL
5050 nathan lane north
plymouth MN 55442
MDR Report Key11108185
MDR Text Key226323186
Report Number3005334138-2020-00651
Device Sequence Number1
Product Code DYB
UDI-Device Identifier05414734203388
UDI-Public05414734203388
Combination Product (y/n)N
PMA/PMN Number
K061015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 01/27/2021
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 Date04/30/2023
Device Model Number406849
Device Catalogue Number406849
Device Lot Number7510934
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/12/2021
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/17/2020
Initial Date FDA Received01/04/2021
Supplement Dates Manufacturer Received01/27/2021
01/27/2021
Supplement Dates FDA Received01/27/2021
01/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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