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

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)).

• Brand Name: TORQVUE SHEATH 12F 100CM 45X45 PKG STER
• Type of Device: TORQVUE 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 Key: 6015659
• MDR Text Key: 56928692
• Report Number: 2135147-2016-00098
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• 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 Received: 10/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/31/2019
• Device Model Number: 9-TV45X45-12F-100
• Device Catalogue Number: 9-TV45X45-12F-100
• Device Lot Number: 5455520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2016
• 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
• Patient Outcome(s): Required Intervention