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

Model Number	9-SB-018
Medical Device Problem Codes	Deflation Problem (1149); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on (b)(6) 2025 a 14 mm amplatzer septal occluder was selected for implant using a 7f amplatzer trevisio intravascular delivery system.All devices were prepared per instructions for use (ifu).Sizing was done with an 18 mm amplatzer sizing balloon ii.While deflating the sizing balloon, air could not be released.Upon inspection the hub of the balloon appeared to be cracked.A new sizing balloon was used to complete sizing.During the procedure it was noted that there was resistance when inserting the delivery system into the patient and advancing the delivery system through the patient anatomy.The occluder could not be advanced through the delivery system.The delivery system was replaced with a new 8f amplatzer trevisio intravascular delivery system to complete the procedure.The patient remained hemodynamically stable throughout the procedure.There were no adverse effects to the patient.The patient status was stable.
Additional Manufacturer Narrative
The device is not returning for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of deflation problem due to fractured balloon 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.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 were no complaints associated with any other devices from the lot.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
It was reported on (b)(6) 2025 a 14mm amplatzer septal occluder was selected for implant using a 7f amplatzer trevisio intravascular delivery system.All devices were prepared per instructions for use (ifu).Sizing was done with an 18mm amplatzer sizing balloon ii.While deflating the sizing balloon, air could not be released.Upon inspection the hub of the balloon appeared to be cracked.A new sizing balloon was used to complete sizing.During the procedure it was noted that there was resistance when inserting the delivery system into the patient and advancing the delivery system through the patient anatomy.The occluder could not be advanced through the delivery system.The delivery system was replaced with a new 8f amplatzer trevisio intravascular delivery system to complete the procedure.The patient remained hemodynamically stable throughout 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: 22982575
• Report Number: 2135147-2025-05046
• Device Sequence Number: 9370984
• Product Code: MJN
• UDI-Device Identifier: 00811806011516
• UDI-Public: (01)00811806011516(17)280131(10)10731154
• 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): 10/14/2025

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 Model Number: 9-SB-018
• Device Catalogue Number: 9-SB-018
• Device Lot Number: 10731154
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2025
• Supplement Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/18/2025
• 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: Male