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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER TORQVUE DELIVERY SYSTEM CATHETER, PERCUTANEOUS

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ABBOTT MEDICAL AMPLATZER TORQVUE DELIVERY SYSTEM CATHETER, PERCUTANEOUS Back to Search Results
Model Number 9-ITV09F45/80
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Air Embolism (1697)
Event Type  Injury  
Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

 
Event Description

Related manufacturer reference number: 2135147-2021-00176. On an unknown date, a 20mm amplatzer septal occluder was selected for implant using a 9f amplatzer torqvue delivery system. During procedure, as the loader was being connected to the delivery sheath, an air embolism was observed over the delivery sheath and required aspiration from the right coronary artery. The patient was transferred to the intensive care unit (icu) post-procedure. In the icu, an intracerebral event/stroke was observed and the patient was monitored. The patient was reported have been discharged in stable condition to receive rehabilitation for the stroke.

 
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Brand NameAMPLATZER TORQVUE DELIVERY SYSTEM
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
ABBOTT MEDICAL
5050 nathan lane north
plymouth MN 55442
Manufacturer (Section G)
ABBOTT MEDICAL
5050 nathan lane north
plymouth MN 55442
Manufacturer Contact
karen krouse
5050 nathan lane n
plymouth, MN 55442
6517565400
MDR Report Key11871094
MDR Text Key252219965
Report Number2135147-2021-00177
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeGM
PMA/PMN NumberK072313
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/27/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/24/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number9-ITV09F45/80
Device Catalogue Number9-ITV09F45/80
Device LOT Number7594535
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/24/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/21/2020
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 05/24/2021 Patient Sequence Number: 1
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