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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-ITV06F180/80
Device Problems Retraction Problem (1536); Material Twisted/Bent (2981)
Patient Problems Low Blood Pressure/ Hypotension (1914); Complete Heart Block (2627)
Event Date 07/18/2019
Event Type  Injury  
Event Description

Related manufacturer report number : 2135147-2019-00255. On (b)(6) 2019, an amplatzer muscular vsd occluder was selected for implant. The device was deployed but didn't fit the ventricular septal defect. The device was attempted to be retracted, but the occluder didn't collapse and retract into the delivery sheath. The tip of the delivery sheath kept folding in on itself. Meanwhile, the patient went into complete heart block and became hypotensive. The occluder and delivery system were withdrawn from the patient without collapsing the occluder. The procedure was cancelled and the patient was sent to the pediatric intensive care unit for continued monitoring. The heart block resolved without treatment.

 
Manufacturer Narrative

The reported event of an inverted sheath tip was confirmed. Gross morphological examination revealed the tip of the sheath was bent and deformed, consistent with the soft tip inverting. The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization. The cause of the reported event could not be conclusively determined.

 
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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 Key8897452
MDR Text Key154541905
Report Number2135147-2019-00256
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK072313
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/08/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/15/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number9-ITV06F180/80
Device Catalogue Number9-ITV06F180/80
Device LOT Number7003532
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/28/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/13/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/17/2019
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/15/2019 Patient Sequence Number: 1
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