MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER VASCULAR PLUG 4; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Catalog Number 9-AVP038-008

Device Problem Inaccurate Information (4051)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/06/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Na.

Event Description

It was reported that on (b)(6) 2023, an 8mm amplatzer vascular plug iv was chosen for procedure.During device preparation, it was noted there was a discrepancy between the device's outer packaging and inner packaging.On one label, it was stated the compatible catheter's inner diameter to be greater than or equal to 0.038in.On the other label, it stated the compatible catheter's inner diameter to be less than or equal to 0.038in.It was reported the device was still used in the procedure without additional issues or delay with a 0.038 inch inner diameter non-abbott diagnostic catheter.There was no report of any adverse patient consequences to the patient.

Manufacturer Narrative

An event of mislabeling was confirmed.The investigation found the complaint is in scope of capa 128015 and the devices were determined to be used as is.

• Brand Name: AMPLATZER VASCULAR PLUG 4
• Type of Device: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18073417
• MDR Text Key: 327401890
• Report Number: 2135147-2023-04870
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00811806012384
• UDI-Public: 00811806012384
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K113658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9-AVP038-008
• Device Lot Number: 8216968
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1