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

Model Number 9-TV45X45-13F-100

Device Problems Difficult To Position (1467); Material Deformation (2976)

Patient Problems Death (1802); Hemorrhage/Bleeding (1888); Tissue Damage (2104)

Event Date 03/03/2014

Event Type  Injury  

Event Description

During the implant of a 24mm amplatzer cardiac plug (acp), there was a problem positioning the amplatzer torqvue 45 x 45 delivery system (size unknown) sheath in the femoral vein.After removing the delivery system, the sheath tip reportedly resembled a rose.Another delivery sheath was used to implant the acp without complication.However, post-procedure the patient experienced retroperitoneal bleeding allegedly due to vein damage.The patient expired.

Manufacturer Narrative

The delivery system's manufacturing records could not be reviewed since the lot number was not provided.However, each delivery system is inspected by certified operators to ensure each lot is acceptable during manufacturing and prior to shipment.The results of this investigation are inconclusive because the product was not returned for analysis and the lot number was unknown.The cause of the reported event remains unknown.

Event Description

A 13f amplatzer torqvue delivery system was used in this procedure and the femoral access was gained 7cm below the inguinal ligament.

Manufacturer Narrative

The 13f tv45x45's dilator was returned to sjm and decontaminated.The dilator was grossly examined and was free of kinks and other physical anomalies.The tip of the dilator was grossly and microscopically examined and contained damage consistent with something sharp coming into contact with the tip.The tip had two cracks, both approximately 3mm in length.The delivery system's manufacturing records could not be reviewed since the lot number was not provided.There was no evidence to suggest there was an intrinsic defect in the dilator and the cause for the dilator tip damage remains unknown.

• Brand Name: AMPLATZER TORQVUE 45X45 DELIVERY SHEATH
• Type of Device: DELIVERY 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 Key: 3701382
• MDR Text Key: 4229550
• Report Number: 2135147-2014-00026
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: K083214
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 9-TV45X45-13F-100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/16/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 9-GW (EXACT MODEL AND LOT UNKNOWN); 9-ACP-007-024
• Patient Outcome(s): Death
• Patient Age: 52 YR
• Patient Weight: 130