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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV BROCKENBROUGH NEEDLE; TROCAR
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MEDTRONIC MEXICO S. DE R.L. DE CV BROCKENBROUGH NEEDLE; TROCAR Back to Search Results
Model Number EP003994S
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Cardiac Tamponade (2226)
Date of Event 05/07/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that during a cryo ablation procedure, cardiac tamponade occurred during the transseptal access.The case was aborted.No further patient complications have been reported as a result of this event.
 
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Brand Name
BROCKENBROUGH NEEDLE
Common Device Name
TROCAR
Manufacturer (Section D)
MEDTRONIC MEXICO S. DE R.L. DE CV
av. paseo del cucapah #10510
tijuana,bc 22210
MX  22210
MDR Report Key11841425
Report Number9617601-2021-00095
Device Sequence Number11548983
Product Code DRC
UDI-Device Identifier00613994663146
UDI-Public00613994663146
Combination Product (Y/N)N
Initial Reporter CountryGR
PMA/510(K) Number
PRE-AMEND
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 05/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date09/25/2022
Device Model NumberEP003994S
Device Catalogue NumberEP003994S
Device Lot Number220827094
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/07/2021
Initial Report FDA Received Date05/18/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
4FC12 SHEATH
Outcome Attributed to Adverse Event Life Threatening;
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