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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC; MEDTRONIC LINE IN DBD-OPEN HEART CDS
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MEDTRONIC; MEDTRONIC LINE IN DBD-OPEN HEART CDS Back to Search Results
Catalog Number CDS983965D
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 04/01/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
It was reported that the tip of the medtronic set cath placement pressure line broke off into the patient.It is unknown how the medtronic set cath placement pressure line was being handled at the time of the incident or how the tip was removed from the patient.No impact or adverse effect to the patient was reported to the pack manufacturer.No additional information was provided to the pack manufacturer.No sample was available to be returned for evaluation.Due to the reported incident, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available, a supplemental medwatch will be filed.
 
Event or Problem Description
It was reported that the tip of the medtronic set cath placement pressure line broke off into the patient.
 
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Common Device Name
MEDTRONIC LINE IN DBD-OPEN HEART CDS
Manufacturer (Section D)
MEDTRONIC
710 medtronic parkway
minneapolis MN 55432 5604
MDR Report Key8536530
Report Number1423395-2019-00016
Device Sequence Number361180
Product Code OEZ
UDI-Device Identifier10889942885961
UDI-Public10889942885961
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/22/2019
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 Catalogue NumberCDS983965D
Device Lot Number18GBQ946
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 04/15/2019
Initial Report FDA Received Date04/22/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other; Required Intervention;
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