MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER TORQVUE 45X45 DELIVERY SHEATH; CATHETER, PERCUTANEOUS

Model Number	9-TV45X45-14F-100
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/08/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2019, a 14f amplatzer torqvue sheath was used to implant an amplatzer amulet.After inserting the 14f sheath in the vena cava inferior, resistance was encountered and the sheath kinked.The user attempted to straighten and manipulate the sheath within the patient to no success.Another 14f amplatzer torqvue sheath was selected and this new sheath kinked as well.A 10f lambre sheath was selected which was able to traverse the patient's anatomy, however, the lambre laao device was unable to be implanted.The procedure was aborted as 320ml of contrast had been used and a future procedure is scheduled.No patient consequences were reported.The patient had highly tortuous anatomy of the femoral artery, and insertion through the transseptal puncture was difficult due to 4 previous punctures for ablation procedures.The user plans to use a balloon in the septum and to implant an amplatzer amulet.
Additional Manufacturer Narrative
The reported event of a kinked sheath was confirmed.Gross morphological examination revealed the sheath was kinked.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; however, according to the site the patient had tortuous anatomy and sheath insertion was difficult due to scarring.

• Brand Name: AMPLATZER TORQVUE 45X45 DELIVERY SHEATH
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 8448112
• Report Number: 2135147-2019-00087
• Device Sequence Number: 11507699
• Product Code: DQY
• UDI-Device Identifier: 00811806014111
• UDI-Public: 00811806014111
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K120120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: 9-TV45X45-14F-100
• Device Catalogue Number: 9-TV45X45-14F-100
• Device Lot Number: 5861294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/15/2019
• Supplement Date Received by Manufacturer: 04/15/2019
• Initial Report FDA Received Date: 03/25/2019
• Supplement Report FDA Received Date: 05/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other