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

Model Number	9-SB-034
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2025, a 34mm amplatzer sizing balloon ii was chosen for an atrial septal defect (asd) closure procedure.During procedure, the sizing balloon was exploded.A new 34mm amplatzer sizing balloon ii was chosen and completed the procedure.The patient was reported stable.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
It was reported that during preparation the sizing balloon was exploded.The device was returned to abbott and the investigation found that the balloon could not be inflated due to the dried crystalized material blocking the inner lumen and entrance into the balloon.The returned state of the device precluded further testing.The cause of reported event could not be determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.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 that on (b)(6) 2025, a 34mm amplatzer sizing balloon ii was chosen for an atrial septal defect (asd) closure procedure.During prepartion, the sizing balloon was exploded.A new 34mm amplatzer sizing balloon ii was chosen and completed the procedure.There was no delay in the procedure and the patient was reported 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: 23617823
• Report Number: 2135147-2025-06776
• Device Sequence Number: 9072595
• Product Code: MJN
• UDI-Device Identifier: 00811806011530
• UDI-Public: (01)00811806011530(17)271231(10)10663168
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 01/13/2026

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-034
• Device Catalogue Number: 9-SB-034
• Device Lot Number: 10663168
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Supplement Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2025
• 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: Unknown