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

Model Number	9-TV45X45-14F-100
Medical Device Problem Codes	Retraction Problem (1536); Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/10/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2019, an amplatzer amulet (size unknown) was selected for implant using a 14f amplatzer delivery sheath.During positioning, the occluder was partially retracted and deployed two times; however, the final position was not optimal for release and the user intended to exchange the amulet for a smaller device.While completely re-sheathing the occluder, the sheath tip was reported to be "wriggled inside".The user applied additional force to retrieve the device which resulted in sheath deformation and distortion.A coronary balloon was inserted over the guide wire to inflate and expand the sheath tip, which allowed the amulet to be partially retracted, but a full re-sheath was not possible.The user elected to remove the dilator and cut its tip then re-insert it over the guide wire.Another attempt was made to re-sheath the device which resulted in the delivery cable to break apart at the "stiff and floppy segment" junction.The amulet was no longer connected to the delivery cable and the system was removed from the patient.Despite only being partially re-sheathed, the amulet remained inside the lumen of the sheath and was removed.No additional attempts were made to deliver another device to the laa and an additional procedure is scheduled for a future time.The patient is stable and no patient consequences were reported.
Additional Manufacturer Narrative
The reported event of a kinked and damaged sheath was confirmed.Gross morphological examination revealed the sheath was kinked and accordion damage was found on the distal end of the sheath.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.

• 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: 8277382
• Report Number: 2135147-2019-00027
• Device Sequence Number: 11151701
• Product Code: DQY
• UDI-Device Identifier: 00811806014111
• UDI-Public: 00811806014111
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: K120120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• 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: 02/28/2019
• Device Model Number: 9-TV45X45-14F-100
• Device Catalogue Number: 9-TV45X45-14F-100
• Device Lot Number: 5434688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/16/2019
• Supplement Date Received by Manufacturer: 04/29/2019
• Initial Report FDA Received Date: 01/25/2019
• 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: Required Intervention
• Patient Age: 80 YR
• Patient Weight: 56