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

Model Number	9-TV45X45-10F-100
Medical Device Problem Codes	Difficult to Insert (1316); Difficult to Advance (2920); Positioning Problem (3009)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event of not being able to deploy the device after retraction was reported.The results of the investigation are inconclusive since the device was not returned for analysis.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.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
On (b)(6) 2019, a 20mm amplatzer cardiac plug was selected for implant with a torque 45x45 10f delivery sheath.The device advanced in the delivery system without difficulties, but was deformed when deployed.The device was retracted.The physician repositioned the device at the intended implant site, but had difficulty advancing the device and the device failed to deploy.The delivery system and the device was removed from the patient.A 13f delivery system (lot # 6203237) and new cardiac plug (lot#6187840) was successfully implanted.The patient remained hemodynamically stable throughout the procedure, although additional sedatives and anticoagulant were needed.There was a clinically significant delay in the procedure due to the additional medication treatment.No patient consequences was reported.

• 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: 9526762
• Report Number: 2135147-2019-00462
• Device Sequence Number: 399386
• Product Code: DQY
• UDI-Device Identifier: 00811806012094
• UDI-Public: 00811806012094
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K083214
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/27/2019

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: 09/30/2020
• Device Model Number: 9-TV45X45-10F-100
• Device Catalogue Number: 9-TV45X45-10F-100
• Device Lot Number: 6187840
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2019
• Initial Report FDA Received Date: 12/27/2019
• 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; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 70