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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC STIFFEN INTRODUCER, CATHETER

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VASCULAR SOLUTIONS LLC STIFFEN INTRODUCER, CATHETER Back to Search Results
Catalog Number 7267V
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 04/04/2022
Event Type  Injury  
Event Description
Teleflex stiffen micro-introducer wire being used during a cardiac catheterization became lodged in the distal abdominal aorta. During removal of the lodged wire, a 12-15cm piece of the wire broke off of the introducer and was unable to be removed. Fda safety report id # (b)(4).
 
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Brand NameSTIFFEN INTRODUCER, CATHETER
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
VASCULAR SOLUTIONS LLC
MDR Report Key14111480
MDR Text Key289345042
Report NumberMW5108981
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 Risk Manager
Type of Report Initial
Report Date 04/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number7267V
Device Lot Number73L2100779
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 04/13/2022 Patient Sequence Number: 1
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