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

Model Number	PVPK2015L20-A
Medical Device Problem Codes	Stretched (1601); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the spiral guidewire uncoiled when removing from the catheter.No harm to the patient was reported.
Additional Manufacturer Narrative
Further information about the event and device information has been requested.A supplemental emdr will be sent when the investigation is completed.
Event or Problem Description
Manufacturer reference # (b)(4).
Additional Manufacturer Narrative
The investigation for customer product complaint related to picco catheter which reported guidewire uncoiled during procedure.The faulty part was not returned so far.There was no patient harm due to issue.However, based on the available information and experience it can be 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: warning: do not withdraw guide wire against needle bevel to avoid possible severing or damage of guide wire.Warning: if resistance is encountered when removing the guide wire, the guide wire could be kinked about tip of catheter within vessel (fig.K).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.

• 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: 21976219
• Report Number: 3003263092-2025-000000
• Device Sequence Number: 21131520
• Product Code: KRB
• UDI-Device Identifier: 04250094500931
• UDI-Public: (01)04250094500931(17)280731(11)230822(10)728449
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2025

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: PVPK2015L20-A
• Device Catalogue Number: 6886148
• Device Lot Number: 728449
• 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: 04/15/2025
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/22/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 123 KG