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

Model Number	9-ITV08F45/80
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Serious Injury
Event or Problem Description
While introducing and advancing the delivery sheath and dilator of the 8f amplatzer torqvue 45 delivery system through a vein, a 2-3 cm portion of the dilatator tip broke off.The delivery sheath and dilator were removed from the patient.The broken piece was snared out from the femoral vein in its entirety.Another 8f amplatzer torqvue 45 delivery system was used to complete the procedure.No patient consequences were reported.The hospital discarded the device and it will not return for investigation.
Additional Manufacturer Narrative
An event of "a 2-3cm portion of the dilatator tip broke off" was reported.The results of the investigation are inconclusive since the device was not returned for analysis; however, seven photos were received from the field.Based solely on the aforementioned photos, the foreign material appeared to be exiting the distal tip of the delivery system under fluoroscopy.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the damage remains unknown.
Event or Problem Description
While introducing and advancing the delivery sheath and dilator of the 8f amplatzer torqvue 45 delivery system through a vein, a 2-3cm portion of the dilator tip broke off.The delivery sheath and dilator were removed from the patient.The broken piece was snared out from the femoral vein in its entirety.Another 8f amplatzer torqvue 45 delivery system was used to complete the procedure.No patient consequences were reported.The young patient's vessels were reported not to be calcified or have torturous anatomy.The hospital discarded the device and it was not returned for investigation.

• Brand Name: AMPLATZER TORQVUE DELIVERY SYSTEM
• Common Device Name: DELIVERY SYSTEM
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 7771154
• Report Number: 2135147-2018-00099
• Device Sequence Number: 1445976
• Product Code: DQY
• UDI-Device Identifier: 00811806010847
• UDI-Public: 00811806010847
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K072313
• 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): 10/24/2018

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: 12/31/2020
• Device Model Number: 9-ITV08F45/80
• Device Catalogue Number: 9-ITV08F45/80
• Device Lot Number: 6297306
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/11/2018
• Supplement Date Received by Manufacturer: 10/04/2018
• Initial Report FDA Received Date: 08/09/2018
• Supplement Report FDA Received Date: 10/24/2018
• 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