MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER SIZING BALLOON II; CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY

Catalog Number	9-SB-024
Medical Device Problem Codes	Difficult to Insert (1316); Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that a 24mm amplatzer sizing balloon ii was selected for a procedure on (b)(6) 2024 to measure the vessel.During the procedure after removing the sheath the sizing balloon was caught under the patient's skin and could not be inserted into the blood vessel.The tip of device appeared to be flared.The device was replaced with a new 34mm amplatzer sizing balloon ii.There were no adverse effects to the patient.The patient status was stable.
Additional Manufacturer Narrative
An event of difficulty advancing the device and material deformation was reported.A returned device inspection, to rule out any device-related causes, could not be performed as the device was not returned for analysis.It was indicated that a was caught under the patient's skin and could not be inserted into the blood vessel.It was also indicated that the tip of device appeared to be flared.A replacement 34 mm amplatzer sizing balloon ii was used to complete the procedure.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.There is no indication of a product quality issue with regards to manufacture, design, or labeling.Per the information available abbott cannot further speculate on why the reported event occurred.

• Brand Name: AMPLATZER SIZING BALLOON II
• Common Device Name: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
• 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: 20161908
• Report Number: 2135147-2024-04390
• Device Sequence Number: 7235917
• Product Code: MJN
• UDI-Device Identifier: 00811806011523
• UDI-Public: (01)00811806011523(17)270531(10)10396786
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K053440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2024

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 Catalogue Number: 9-SB-024
• Device Lot Number: 10396786
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/14/2024
• Supplement Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/21/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown