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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL PEEL-AWAY INTRODUCER 14CM SHEATH INTRODUCER KIT, 6F; INTRODUCER, CATHETER
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ST. JUDE MEDICAL PEEL-AWAY INTRODUCER 14CM SHEATH INTRODUCER KIT, 6F; INTRODUCER, CATHETER Back to Search Results
Model Number 405104
Medical Device Problem Code Difficult or Delayed Separation (4044)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 09/28/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported peeling difficulty remains unknown.
 
Event or Problem Description
During the pacemaker implant procedure, difficulty peeling the introducer caused a procedure delay.Scissors were used to finish peeling the introducer, which added between ten and fifteen minutes to the procedure.There were no adverse patient consequences.
 
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Brand Name
PEEL-AWAY INTRODUCER 14CM SHEATH INTRODUCER KIT, 6F
Common Device Name
INTRODUCER, CATHETER
Manufacturer (Section D)
ST. JUDE MEDICAL
5050 nathan lane north
plymouth MN 55442
MDR Report Key10684052
Report Number3005334138-2020-00494
Device Sequence Number304590
Product Code DYB
UDI-Device Identifier05414734204088
UDI-Public05414734204088
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
K894431
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 10/15/2020
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
Operator of Device Health Professional
Device Expiration Date12/31/2022
Device Model Number405104
Device Catalogue Number405104
Device Lot Number7338430
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/01/2020
Initial Report FDA Received Date10/15/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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