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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH¿ HEMOSTASIS INTRODUCER, CATH-LOCK¿ LOCKING HUB, 12 CM SHEATH, 6.5 F INTRODUCER, CATHETER

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ST. JUDE MEDICAL FAST-CATH¿ HEMOSTASIS INTRODUCER, CATH-LOCK¿ LOCKING HUB, 12 CM SHEATH, 6.5 F INTRODUCER, CATHETER Back to Search Results
Model Number 406704
Device Problem Gas/Air Leak (2946)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/29/2022
Event Type  malfunction  
Event Description
Related manufacturing ref: 3005334138-2022-00467. During a paroxysmal supraventricular tachycardia (psvt) ablation procedure, air was aspirated into a syringe that connected to the extension port of the sheath. Although several aspirations were attempted, air was still noted. The sheath set was replaced however, and air was again aspirated. A third sheath used to complete the procedure with no adverse consequences to the patient.
 
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Brand NameFAST-CATH¿ HEMOSTASIS INTRODUCER, CATH-LOCK¿ LOCKING HUB, 12 CM SHEATH, 6.5 F
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
ST. JUDE MEDICAL
5050 nathan lane north
plymouth MN 55442
Manufacturer (Section G)
ST. JUDE MEDICAL (AFD-PLYMOUTH)
5050 nathan lane north
plymouth MN 55442
Manufacturer Contact
janna parks
5050 nathan lane north
plymouth, MN 55442
6517565400
MDR Report Key15201185
MDR Text Key299405506
Report Number3005334138-2022-00468
Device Sequence Number1
Product Code DYB
UDI-Device Identifier05414734216975
UDI-Public05414734216975
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K061015
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 09/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/10/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number406704
Device Catalogue Number406704
Device Lot Number8277499
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received09/07/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/04/2022
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: 08/10/2022 Patient Sequence Number: 1
Treatment
FAST-CATH HEMO INTRODUCER
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