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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. BOSTON SCIENTIFIC 7F SPLIT SHEATH KIT WITH VALVE AND SIDEPORT INTRODUCER, CATHETER

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MERIT MEDICAL SYSTEMS, INC. BOSTON SCIENTIFIC 7F SPLIT SHEATH KIT WITH VALVE AND SIDEPORT INTRODUCER, CATHETER Back to Search Results
Catalog Number M0D4 8087001
Device Problems Break (1069); Device Dislodged or Dislocated (2923)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/18/2022
Event Type  malfunction  
Event Description
During pacemaker insertion, sheath broke during 'peel­ away' dislodging atrial lead.
 
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Brand NameBOSTON SCIENTIFIC 7F SPLIT SHEATH KIT WITH VALVE AND SIDEPORT
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
MERIT MEDICAL SYSTEMS, INC.
MDR Report Key15094920
MDR Text Key296604167
Report NumberMW5111091
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 07/21/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/22/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberM0D4 8087001
Device Lot NumberQ1868740
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

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