MAUDE Adverse Event Report: PULSION MEDICAL SYSTEMS SE PICCO KIT; PROBE, THERMODILUTION

Model Number	6885060
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Further information about the event has been requested.A supplemental emdr will be sent when the investigation is completed.
Event or Problem Description
It was reported that picco catheter had a crack resulting in leakage after the fixation wing during injection.There was no patient harm.Manufacturer's ref.#: (b)(4).

• Brand Name: PICCO KIT
• Common Device Name: PROBE, THERMODILUTION
• Manufacturer (Section D): PULSION MEDICAL SYSTEMS SE; hans-riedl-strasse 17; feldkirchen 85622 ; GM 85622
• Manufacturer (Section G): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna 85622 ; GM 85622
• Manufacturer Contact: caroline kabbabe ; roentgenvagen 2; solna 85622 ; GM 85622 ; 0894599140
• MDR Report Key: 24574043
• Report Number: 3003263092-2026-000000
• Device Sequence Number: 10355347
• Product Code: KRB
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K171620
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2026

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: 6885060
• Device Lot Number: 801494
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2026
• Supplement Date Received by Manufacturer: 07/16/2026
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 07/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown