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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. FAST-CATH INTRODUCER, CATHETER

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ST. JUDE MEDICAL, INC. FAST-CATH INTRODUCER, CATHETER Back to Search Results
Model Number 406701
Device Problems Break (1069); Migration or Expulsion of Device (1395)
Patient Problem Foreign Body In Patient (2687)
Event Date 07/06/2022
Event Type  malfunction  
Event Description
Upon removing a 6 fr short sheath it was noted that a part had broken off. The portion of sheath was noted on fluoroscopy. This occur and/or noted when suturing the insertion site. A snare was used to retrieve the sheath. The site was re-accessed to allow for snare insertion and tip of sheath retrieval which had migrated toward the right ventricular region. Physician removed fragment of 6 fr broken sheath using snare. There was not apparent injury to patient. Patient was unaware of issue at the time of occurrence as conscious sedation.
 
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Brand NameFAST-CATH
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.
5050 nathan lane north
plymouth MN 55442
MDR Report Key15209617
MDR Text Key297699795
Report Number15209617
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/03/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/11/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number406701
Device Catalogue Number406701
Device Lot Number8458176
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/03/2022
Event Location Hospital
Date Report to Manufacturer08/11/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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