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

Model Number	6885049
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that picco catheter was stuck and it was only possible to remove it after multiple attempts.The wire fell apart.There was no patient harm.Manufacturer reference (b)(4).
Additional Manufacturer Narrative
After the insertion of the wire through the seldinger needle, at the adjustment of the wire, it was difficult to withdraw the wire.No part of the seldinger wire remained inside the patient¿s body and no additional medical procedure was required to remove the catheter.Pictures of the broken picco catheter was provided and the reported issue was confirmed.The defective part has been discarded and could not be returned.The cause of the issue could be determined as related to separated guidewire.Overall, investigations did indicate that the device failed to meet its specification when the event occurred.A relationship between the device and the complaint is therefore considered as likely.Upon the complaint occurrence the device was involved and used on a patient for advanced hemodynamic monitoring.In general a monitoring technology is considered as diagnostic aid, but not directly used for diagnosis or treatment.

• 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: 25031370
• Report Number: 3003263092-2026-000001
• Device Sequence Number: 13286122
• Product Code: KRB
• UDI-Device Identifier: 04250094500931
• UDI-Public: (01)04250094500931(17)300731(11)250807(10)801753
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/29/2026

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: 6885049
• Device Lot Number: 801753
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/07/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown