MAUDE Adverse Event Report: Abbott Medical HF Sensor Delivery System; System, Hemodynamic, Implantable

Model Number	CM2000
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During the implant of the sensor, the sensor did not release from the distal end of the delivery catheter.The physician could not remove the sensor from the delivery catheter.The physician had to perform a second access site through the femoral vein to put the swan up.The balloon catheter was able to knock the sensor off of the catheter.The sensor was successfully implanted.
Additional Manufacturer Narrative
The investigation codes along with investigation results will be provided in a subsequent submission.

• Brand Name: HF Sensor Delivery System
• Common Device Name: System, Hemodynamic, Implantable
• Manufacturer (Section D): Abbott Medical; 387 nerem st nw suite 500; atlanta GA 30313
• Manufacturer (Section G): Abbott Medical; 387 nerem st nw suite 500; atlanta GA 30313
• Manufacturer Contact: fredric gold ; 168 middlesex turnpike; burlington, MA 01803 ; +1(651)756-5400
• MDR Report Key: 50801392
• Report Number: 3004936110-2026-01586
• Device Sequence Number: 12922551
• Product Code: MOM
• UDI-Device Identifier: 05414734509237
• UDI-Public: (01)05414734509237(10)10967648(17)270728
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P100045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: CM2000
• Device Catalogue Number: CM2000
• Device Lot Number: 10967648
• Was Device Available for Evaluation?: No
• 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: 09/04/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/28/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 116 LB