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

Model Number	PV2014L16-A
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation for customer product complaint related to picco catheter was performed.There was no patient harm due to issue.It was discovered that the puncture needle connector had cracked when connecting the syringe, causing blood to flow out from the crack.This incident resulted in increased blood loss for the patient during the puncture procedure.The crack can be confirmed in provided picture.No harm to patient was reported.Unfortunately, customer did not send part back for investigation.A relationship between the device and the complaint is therefore considered, in worst case scenario, as likely.Information indicates that upon the complaint occurrence the device was involved and used on a patient for advanced hemodynamic monitoring.The cause of the issue could be determined as related to cracked tubing.Based on the information stated above, no additional actions will be taken.
Event or Problem Description
It was reported that puncture needle connector had cracked when connecting the syringe, causing blood to flow out from the crack.No harm to patient was reported.The manufacturer's reference #: (b)(4).

• Brand Name: PICCO CATHETER
• Common Device Name: PROBE, THERMODILUTION
• Manufacturer (Section D): PULSION MEDICAL SYSTEMS SE; hans-riedl-strasse 17; feldkirchen 85622 ; GM 85622
• Manufacturer (Section G): PULSION MEDICAL SYSTEMS SE; hans-riedl-strasse 17; feldkirchen 85622 ; GM 85622
• Manufacturer Contact: nicole kammermaier ; hans-riedl-strasse 17; feldkirchen 85622 ; GM 85622 ; 0894599140
• MDR Report Key: 23462738
• Report Number: 3003263092-2025-000002
• Device Sequence Number: 9085410
• Product Code: KRB
• UDI-Device Identifier: 24250094500966
• UDI-Public: (01)24250094500966(17)290331(11)240410(10)800362
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/04/2025

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: PV2014L16-A
• Device Catalogue Number: 6885046
• Device Lot Number: 800362
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2025
• Initial Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/10/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male