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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER TORQVUE 45X45 DELIVERY SHEATH DELIVERY SYSTEM

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AGA MEDICAL CORPORATION AMPLATZER TORQVUE 45X45 DELIVERY SHEATH DELIVERY SYSTEM Back to Search Results
Model Number 9-TV45X45-14F-100
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Hemostasis (1895); Blood Loss (2597)
Event Date 04/14/2015
Event Type  Injury  
Event Description

A combined cryoablation and left atrial appendage occlusion case was performed under general anesthetic. Following the successful and uneventful implantation of the 31 mm amplatzer amulet with a 14f amplatzer torqvue 45x45 delivery sheath (tv45x45), the physician opted to observe the patient for ten minutes before removing any sheaths while the patient was under general anesthetic. During the observation period, a hemoglobin (hb) was obtained and there was a decrease from a baseline hb level of 13 to 6-7 at procedure completion. Cpr was required for approximately 5-10 minutes, as well as blood transfusion due to clinical deterioration. The patient stabilized with a systolic pressure of 113mmhg. A diagnostic angiogram performed on both groins and descending aorta, was unable to determine the source of bleeding. A ct scan confirmed a retro-peritoneal bleed and surgery was required. The patient has now recovered and is being maintained on anticoagulation. The 14f tv45x45 sheath could not be ruled out as the cause.

 
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.

 
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Brand NameAMPLATZER TORQVUE 45X45 DELIVERY SHEATH
Type of DeviceDELIVERY SYSTEM
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 Key4761855
MDR Text Key5776673
Report Number2135147-2015-00051
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUK
PMA/PMN NumberK120120
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/16/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/11/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/30/2017
Device MODEL Number9-TV45X45-14F-100
Device Catalogue Number9-TV45X45-14F-100
Device LOT Number4947294
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received04/16/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/01/2014
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: 05/11/2015 Patient Sequence Number: 1
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