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

Model Number 9-ITV05F180/60

Device Problem Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/19/2020

Event Type  malfunction  

Manufacturer Narrative

Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

Related manufacturing reference number 2135147-2020-00335.On (b)(6) 2020, a 5f amplatzer torqvue delivery system (lot#6428039) was selected to implant a 9-pda- 003 device(lot#597768).During the canal duct occlusion procedure, the device was unable to be introduced in the delivery system.The delivery system was exchanged for another 5f amplatzer torqvue delivery system (lot#7165240) and the device was also exchanged for another 9-pda-003 device(lot#7249390), but again the 9-pda-003 device was unable to be introduced into this delivery system.The physician decided to exchange the delivery system and device for a 6f amplatzer torqvue delivery system(lot#7237301) and a 9 pda-004 device(lot#6914380), but the patient's anatomy was too small for this delivery system.The physician decided to close the patent ductus arteriosus with a coil (cook im wce 3 pda5).There was a clinically significant delay in the procedure, but the patient remained stable throughout the procedure.The patient is currently stable and discharged.The physician believed that the first two sheaths used in the procedure were too small for the devices.Later, another physician was able to fit the device onto the sheath but there was too much friction.

Manufacturer Narrative

The reported event of advancement difficulty could not be confirmed.A more comprehensive assessment could not be performed 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.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: AMPLATZER TORQVUE DELIVERY SYSTEM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10347467
• MDR Text Key: 201363012
• Report Number: 2135147-2020-00334
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00811806010755
• UDI-Public: 00811806010755
• Combination Product (y/n): N
• PMA/PMN Number: K072313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: 9-ITV05F180/60
• Device Catalogue Number: 9-ITV05F180/60
• Device Lot Number: 6428039
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 9-ITV05F180/60 (LOT#7165240)