MAUDE Adverse Event Report: ABBOTT MEDICAL Mechanical Sizer Set; Sizer, Heart-Valve, Prosthesis

Model Number	905
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is unknown if the device is returning for analysis.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2026, a mechanical valve sizer was chosen for a procedure.During procedure, it was noted that the plastic fracture at the handle of the valve sizer occurred in the hospital.The distributor has confirmed with the hospital that the hospital adopts one of the disinfection methods specified in the chinese user manual of the valve sizer.The hospital inspects the valve sizer for cracks and damage before and after each disinfection.Subsequently, the surgeon replaced the valve sizer and valves with products from other manufacturers to complete the operation.The patient has recovered and been discharged.
Event or Problem Description
It was reported that on (b)(6)2026, a mechanical valve sizer was chosen for a procedure.During procedure, it was noted that the plastic fracture at the handle of the valve sizer occurred in the hospital.The distributor has confirmed with the hospital that the hospital adopts one of the disinfection methods specified in the chinese user manual of the valve sizer.The hospital inspects the valve sizer for cracks and damage before and after each disinfection.Subsequently, the surgeon replaced the valve sizer and valves with products from other manufacturers to complete the operation.The patient has recovered and been discharged.
Additional Manufacturer Narrative
An event of damaged mechanical sizers was reported.Information from the field indicated that during procedure, it was noted that the plastic fracture at the handle of the valve sizer occurred in the hospital.A photo was received from the field showing the breakage.A returned device assessment could not be performed as the device was not returned for analysis.A detailed device history record (dhr) review was conducted, including an assessment of the applicable manufacturing and inspection records.The review found that all products were manufactured and inspected in compliance with established procedures, and all operations were performed in accordance with approved manufacturing and inspection requirements.Based on the available information, the cause for the reported event could not conclusively be determined but could be as a result of a combination of shipping, storage and handling.There is no indication of a product issue with respect to manufacture, design or labeling.

• Brand Name: Mechanical Sizer Set
• Common Device Name: Sizer, Heart-Valve, Prosthesis
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): Abbott Medical Reg#3007113487; 177 county road b east; st. paul MN 55117 -178
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; +1(651)756-5400
• MDR Report Key: 25435918
• Report Number: 2135147-2026-03871
• Device Sequence Number: 21410031
• Product Code: DTI
• UDI-Device Identifier: 05415067042330
• UDI-Public: (01)05415067042330(11)251001(10)11065317
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: Exempt
• 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,Followup
• Report Date (Section B): 10/01/2026

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: 905
• Device Catalogue Number: 905
• Device Lot Number: 11065317
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/04/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2026
• Supplement Date Received by Manufacturer: 08/27/2026; 09/28/2026
• Initial Report FDA Received Date: 06/08/2026
• Supplement Report FDA Received Date: 09/01/2026; 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2025
• 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 Age: 75 YR
• Patient Sex: Female