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U.S. Department of Health and Human Services

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

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ST. JUDE MEDICAL STEERABLE INTRODUCER INTRODUCER, CATHETER Back to Search Results
Catalog Number REF 408310
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/28/2022
Event Type  malfunction  
Event Description
Patient presented for a cardiac ablation, during procedure provider noted a foreign body on tip of transseptal sheath, sheath was removed intact with foreign body, procedure completed with new sheath in use, patient tolerated well. No patient harm. Fda safety report id# (b)(4).
 
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Brand NameSTEERABLE INTRODUCER
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
ST. JUDE MEDICAL
MDR Report Key13454214
MDR Text Key285223472
Report NumberMW5107205
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 02/01/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/03/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberREF 408310
Device Lot Number8193882
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/01/2022
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

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