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U.S. Department of Health and Human Services

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

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AGA MEDICAL CORPORATION AMPLATZER TORQVUE DELIVERY SYSTEM CATHETER, PERCUTANEOUS Back to Search Results
Model Number 9-ITV10F45/80
Device Problem Material Perforation (2205)
Patient Problems Perforation (2001); Pericardial Effusion (3271)
Event Date 07/17/2019
Event Type  Injury  
Manufacturer Narrative

Further information regarding this event has been requested. The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

 
Event Description

On (b)(6) 2019, a 16mm amplatzer muscular vsd occluder was selected for implant. The procedure was complex as the patient's defect was very apical. There was also the presence of a pseudo-aneurysm located on the lateral wall of the vd (ventricle defect) and a litany of trabeculations. As the physician was getting ready to deploy the device and a pericardial effusion on the lateral side of the vd was noted. The physician quickly deployed the occluder and punctured the pericardium. 220cc of blood was extracted and after 125 minutes, a pericardial drain was set in place and the bleeding stopped. The procedure took longer than anticipated. The patient is reported to be in stable condition. Manufacturer report number: 2135147-2019-00223.

 
Manufacturer Narrative

Correction: upon review, the delivery system should not have been submitted as a medical device report (mdr) as the event did not indicate a malfunction caused a serious event.

 
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Brand NameAMPLATZER TORQVUE DELIVERY SYSTEM
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
AGA MEDICAL CORPORATION
5050 nathan lane north
plymouth MN 55442
Manufacturer (Section G)
AGA MEDICAL CORPORATION
5050 nathan lane north
plymouth MN 55442
Manufacturer Contact
stephanie o' sullivan
5050 nathan lane north
plymouth, MN 55442
6517565400
MDR Report Key8865392
MDR Text Key153538162
Report Number2135147-2019-00224
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeCA
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 10/21/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/06/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number9-ITV10F45/80
Device Catalogue Number9-ITV10F45/80
Device LOT Number7043953
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 Received10/21/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/13/2019
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: 08/06/2019 Patient Sequence Number: 1
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