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

Catalog Number	9-SB-018
Medical Device Problem Codes	Difficult to Advance (2920); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2024
Type of Reportable Event	Malfunction
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 after insertion, it was observed that the tip of the balloon split and could not advance through the patent foramen ovale (pfo).The split tip was noted after the balloon made contact with the guidewire.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Abbott also requested for image of the device/issue which was not provided by the field.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.
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 an 18mm amplatzer sizing balloon ii was selected for a procedure on (b)(6) 2024.During the procedure it was noted that there was difficulty inserting the balloon into the patient.After insertion, it was observed that the tip of the balloon split and could not advance through the patent foramen ovale (pfo).The split tip was noted after the balloon made contact with the guidewire.The device was removed from the patient.A 25mm sized device was chosen through transesophageal echocardiography (tee) measurements.The patient remained hemodynamically stable throughout the procedure.There were no clinically significant delays in the procedure.There were no adverse effects to the patient.The patient status was stable.

• 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: 20942788
• Report Number: 2135147-2024-06408
• Device Sequence Number: 12795868
• Product Code: MJN
• UDI-Device Identifier: 00811806011516
• UDI-Public: (01)00811806011516(17)270331(10)10291793
• 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): 01/10/2025

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-018
• Device Lot Number: 10291793
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2024
• Supplement Date Received by Manufacturer: 12/28/2024
• Initial Report FDA Received Date: 12/16/2024
• Supplement Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/09/2024
• 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 Age: 55 YR
• Patient Sex: Female