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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AGA MEDICAL CORPORATION TORQVUE SHEATH 12F 100CM 45X45 PKG STER TORQVUE 45 X 45 DELIVERY SHEATH

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AGA MEDICAL CORPORATION TORQVUE SHEATH 12F 100CM 45X45 PKG STER TORQVUE 45 X 45 DELIVERY SHEATH Back to Search Results
Model Number 9-TV45X45-12F-100
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pulmonary Embolism (1498)
Event Date 08/16/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4). The results of the investigation are inconclusive since the device was not returned for analysis. Our investigation was limited to the review of the device history record, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with sjm specifications and procedures. Based on the information received, the cause of the reported incident could not be conclusively determined.

 
Event Description

On (b)(6) 2016, an amplatzer amulet (acp2) was implanted using a 12f amplatzer torqvue 45 x 45 delivery sheath (tv45x45). On (b)(6) 2016, bilateral pulmonary emboli were observed. The patient was hospitalized and treated with heparin which led to thrombocytopenia. Heparin was discontinued and coumadin was started. (clinical study patient id: (b)(6)).

 
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Brand NameTORQVUE SHEATH 12F 100CM 45X45 PKG STER
Type of DeviceTORQVUE 45 X 45 DELIVERY SHEATH
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
denise johnson
5050 nathan lane north
plymouth, MN 55442
6517564470
MDR Report Key6015659
MDR Text Key56928692
Report Number2135147-2016-00098
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 09/22/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/10/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device EXPIRATION Date03/31/2019
Device MODEL Number9-TV45X45-12F-100
Device Catalogue Number9-TV45X45-12F-100
Device LOT Number5455520
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/22/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/07/2016
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: 10/10/2016 Patient Sequence Number: 1
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