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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL ULTIMUM HEMOSTASIS INTRODUCER INTRODUCER, CATHETER

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ST. JUDE MEDICAL ULTIMUM HEMOSTASIS INTRODUCER INTRODUCER, CATHETER Back to Search Results
Model Number 407831
Device Problem Component Misassembled (4004)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/22/2021
Event Type  malfunction  
Manufacturer Narrative
Fsca number: (b)(4). The device was not returned; however, images provided showed that the returned dilator did not reach the distal end of the sheath while engaged. Further investigation revealed the sheath length did not meet manufacturing specifications, as a 12cm fast-cath hemo was processed and packaged in place of a 5cm ultimum hemo. Length measurements confirmed there was a component mix, which has been determined to be manufacturing related.
 
Event Description
During device preparation, when the sheath was flushed and the dilator was inserted into the sheath, it was noted that the sheath was longer than the dilator. The introducer was replaced, and the same issue was noted. Another introducer of a different lot was used to complete the procedure successfully with no adverse patient consequences. All boxes of lot number 7748246 to be returned ((b)(4) units). The used devices were discarded.
 
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Brand NameULTIMUM HEMOSTASIS INTRODUCER
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
ST. JUDE MEDICAL
5050 nathan lane north
plymouth MN 55442
Manufacturer (Section G)
ST. JUDE MEDICAL
5050 nathan lane north
plymouth MN 55442
Manufacturer Contact
janna parks
5050 nathan lane north
plymouth, MN 55442
6517565400
MDR Report Key12869311
MDR Text Key281980178
Report Number3005334138-2021-00757
Device Sequence Number1
Product Code DYB
UDI-Device Identifier05414734008808
UDI-Public05414734008808
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K031137
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Remedial Action Recall
Type of Report Initial
Report Date 11/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number407831
Device Catalogue Number407831
Device Lot Number7748246
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/12/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/20/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberSEE H10

Patient Treatment Data
Date Received: 11/24/2021 Patient Sequence Number: 1
Treatment
ULTIMUM HEMOSTASIS INTRODUCER X39
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