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

Catalog Number	9-SB-034
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	07/25/2024
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 on (b)(6) 2024, a 34mm amplatzer sizing balloon was chosen to measure an atrial septal defect (asd).The balloon could not be inserted into the vessel as it would catch on skin at the access site.Access site was expanded using forceps, and it still did not insert.The tip of the sizing balloon was observed to be flared and bent up.A replacement 34mm amplatzer sizing balloon (lot: 9156076) was used to complete the procedure successfully.There were no reported patient effects or clinically significant delay.
Additional Manufacturer Narrative
An event of difficulty inserting the device into patient anatomy and material deformation was reported.A returned device assessment 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.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on the information received, the cause of the reported insertion difficulty could not be conclusively determined.It is possible patient anatomy contributed to the insertion difficulty; however, this could not be confirmed.The reported material deformation is consistent with damage during use.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• 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: 20015387
• Report Number: 2135147-2024-04041
• Device Sequence Number: 7476139
• Product Code: MJN
• UDI-Device Identifier: 00811806011530
• UDI-Public: (01)00811806011530(17)260630(10)9156076
• 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): 09/25/2024

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: 06/30/2026
• Device Catalogue Number: 9-SB-034
• Device Lot Number: 9156076
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/25/2024
• Supplement Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/26/2023
• 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: Unknown