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); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2024
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/ na.
Event or Problem Description
It was reported that on (b)(6) 2024, a 24mm amplatzer sizing balloon ii was chosen to size the septal defect prior to a patent foramen ovale (pfo) closure.The physician noted that part of the balloon was "folded" instead of being in a flat state, which was making the insertion more difficult in the patient.Inflating and deflating was not changing or unfolding the balloon.The sizing balloon was able to be used and the procedure was completed.The patient was reported to be discharged.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.
Additional Manufacturer Narrative
An event of part of the balloon being "folded" making the insertion difficult in the patient was reported.The investigation confirmed the balloon membrane met functional specifications when analyzed at abbott.The balloon was inflated and deflated with ease with water and no anomalies were noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the reported event could not be conclusively determined.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) 2024, a 24mm amplatzer sizing balloon ii was chosen to size the septal defect prior to a patent foramen ovale (pfo) closure.The physician noted that part of the balloon was "folded" instead of being in a flat state, which was making the insertion more difficult in the patient.Inflating and deflating was not changing or unfolding the balloon.The sizing balloon was able to be used and the procedure was completed.The patient was reported to be discharged.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.

• 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: 18937382
• Report Number: 2135147-2024-01244
• Device Sequence Number: 12505416
• Product Code: MJN
• UDI-Device Identifier: 00811806011523
• UDI-Public: (01)00811806011523(17)260131(10)8905650
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 05/06/2024

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 Expiration Date: 01/31/2026
• Device Catalogue Number: 9-SB-024
• Device Lot Number: 8905650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/23/2024
• Supplement Date Received by Manufacturer: 04/26/2024
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 05/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2023
• 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