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

Model Number	PV2015L20-A
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2025
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 during the insertion of a picco catheter the guidewire got stuck.While retracting the guidewire, it completely frayed out.No harm to the patient was reported.
Additional Manufacturer Narrative
The investigation for customer product complaint registered in onetrack system under number (b)(4) related to picco catheter which reported guidewire frayed out during retraction was performed.The faulty part was returned for in-house investigation.The issue was confirmed.There was no patient harm due to issue.It was concluded that the most probable cause of the issue was need to use excessive force to retract stuck guidewire.There is no indication for a systematic root cause as a deficiency of design, production or material.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.Please note, that according to ifu for picco catheter: "do not withdraw guide wire against needle bevel to avoid possible severing or damage of guide wire.If resistance is encountered when removing the guide wire, the guide wire could be kinked about tip of catheter within vessel.In this case withdraw the catheter by 2 to 3 cm and try again to remove the guide wire.Use of excessive force may tear off the guide wire.Therefore, guide wire and catheter are to be removed simultaneously." based on the information above this customer product complaint will be closed.
Event or Problem Description
Manufacturer 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: 21675509
• Report Number: 3003263092-2025-000000
• Device Sequence Number: 7768207
• Product Code: KRB
• UDI-Device Identifier: 04250094500931
• UDI-Public: (01)04250094500931(17)290930(11)241015(10)800973
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K171620
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2025

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: PV2015L20-A
• Device Catalogue Number: 6885049
• Device Lot Number: 800973
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2025
• Supplement Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 03/24/2025
• Supplement Report FDA Received Date: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown