MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER VASCULAR PLUG II; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	9-AVP2-014
Medical Device Problem Codes	Difficult to Insert (1316); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Further information regarding this event has been requested.The investigation results will be provided in a subsequent submission.
Event or Problem Description
On (b)(6) 2020, a 14mm amplatzer vascular plug ii(avpii) was selected for embolization in the left internal iliac artery via the right femoral artery.When the avpii was attempted to insert into a 6fr flexor ansel guiding sheath(by cook medical), there was large resistance felt advancing the avpii from the loader near the catheter hub; the avpii could not be inserted into the guiding sheath.When the avpii was removed, and confirmed outside of the patient body, about 10mm away from the tip of the pusher wire was found to have kinked.A 14mm amplatzer vascular plug(avp) was used instead and the procedure was completed successfully.Other than the procedure delay, there was no adverse consequence to the patient.Although there might be possibility of the guiding sheath lumen being flat, there was no vessel tortuosity where the loader and the catheter hub was placed inside the patient, and therefore, the physician does not think the catheter lumen shape was the cause, but details are unknown.Besides, the replacement avp was able to deliver through the sheath without any resistance.
Additional Manufacturer Narrative
The reported event of resistance when advancing the plug from the loader to the delivery sheath and a kink at the tip of the pusher wire could not be confirmed.A more comprehensive assessment could not be performed as 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 VASCULAR PLUG II
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 11011096
• Report Number: 2135147-2020-00542
• Device Sequence Number: 4563327
• Product Code: KRD
• UDI-Device Identifier: 00811806010403
• UDI-Public: 00811806010403
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K071125
• 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): 12/16/2020

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: 01/31/2025
• Device Model Number: 9-AVP2-014
• Device Catalogue Number: 9-AVP2-014
• Device Lot Number: 7389298
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/19/2020
• Supplement Date Received by Manufacturer: 12/15/2020
• Initial Report FDA Received Date: 12/15/2020
• Supplement Report FDA Received Date: 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1