MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER TORQVUE DELIVERY SYSTEM; CATHETER, PERCUTANEOUS

Model Number	9-ITV05F180/60
Medical Device Problem Codes	Difficult to Insert (1316); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Further information regarding this event has been requested.If returned, investigation results will be provided in a subsequent submission.
Event or Problem Description
It was not possible to advance a ado size 3, from the loader to the apropriate 5f ds.Everything had to be changed to a 6f ds.The 6f ds was to big to cross the pda (very narrow at the pulmonary artery size) the ado (mounted in the cable) was back loaded in the initial 5f ds to test the ds inner diameter.It was possible to pull in the device and to pull it outfrom the ds hub the cardiologist concluded the problem was the connection between the loader and the ds.The loader screw was cut out.The 5f ds was again inserted in the patient.The cardiologist did a "direct connection" of the cut loader with the ds, and advanced.The ado into the ds under constant manual saline flush to avoid ar coming in.The ado was correctly implanted.
Additional Manufacturer Narrative
Additional information sections: b5, d10, h2, h3, h6, h10.An event of difficulty advancing the occluder into the sheath could not be confirmed.The investigation confirmed the device met dimensional and functional specifications when analyzed at abbott.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 TORQVUE DELIVERY SYSTEM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 9882861
• Report Number: 2182269-2020-00030
• Device Sequence Number: 11450572
• Product Code: DQY
• UDI-Device Identifier: 00811806010755
• UDI-Public: 00811806010755
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2020

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: 09/30/2020
• Device Model Number: 9-ITV05F180/60
• Device Catalogue Number: 9-ITV05F180/60
• Device Lot Number: 6180377
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/28/2020
• Supplement Date Received by Manufacturer: 05/04/2020
• Initial Report FDA Received Date: 03/26/2020
• Supplement Report FDA Received Date: 05/22/2020
• 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: Hospitalization
• Patient Age: 21 MO