MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER DUCT OCCLUDER; OCCLUDER, PATENT DUCTUS, ARTERIOSUS

Model Number	9-PDA-006
Medical Device Problem Codes	Break (1069); Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The results, method, and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
Related manufacturer report number: 2135147-2021-00128.On (b)(6) 2021, a 10-8 mm amplatzer duct occluder was selected to close off a duct created by a transcaval tavr procedure.A torqvue device loader was used together with an agilis catheter.During the loading of the device there was some resistance noted.The physician positioned the device and deployed the distal end (not fully), while trying to find the optimal position it was noted that the device had become detached from the torqvue delivery cable.An ensnare was then used to snared and remove the device through the agilis catheter.Upon inspection it was noted that the threads of the endscrew of the torqvue delivery cable broke off in the endscrew on the occluder.A new 6 mm amplatzer duct occluder and torqvue were used to complete the procedure.There was no clinically significant delay in the procedure and the patient remained hemodynamically stable throughout.The patient was discharged the following day and is stable.
Additional Manufacturer Narrative
An event of the delivery cable breaking off inside the endscrew of the occluder was confirmed.Gross examination found that the endscrew of the delivery cable had broken off and remained inside the endscrew of the occluder.No other anomalies were found to the occluder.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the reported event could not be conclusively determined.

• Brand Name: AMPLATZER DUCT OCCLUDER
• Common Device Name: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 11609688
• Report Number: 2135147-2021-00127
• Device Sequence Number: 3280538
• Product Code: MAE
• UDI-Device Identifier: 00811806011134
• UDI-Public: 00811806011134
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: 9-PDA-006
• Device Catalogue Number: 9-PDA-006
• Device Lot Number: 6076447
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/05/2021
• Supplement Date Received by Manufacturer: 05/07/2021
• Initial Report FDA Received Date: 04/02/2021
• Supplement Report FDA Received Date: 05/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1