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

Model Number	PV2014L22-A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2025
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 when inserting the catheter, the needle tip (pink) got caught on the guide wire.
Event or Problem Description
Manufacturer reference #(b)(4).
Additional Manufacturer Narrative
The investigation for customer product complaint related to picco catheter which reported that guide wire was caught at the needle tip when inserting the catheter was performed.There was no patient harm due to issue.The faulty part was not returned for in-house investigation, no picture was provided, so the issue could not be confirmed.The cause of the issue could not be determined.Overall, it is not possible to define if the device failed to meet its specification when the problem occurred.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.Based on the information stated above, no additional actions will be taken and this customer product complaint will be closed.

• 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: 21525692
• Report Number: 3003263092-2025-000000
• Device Sequence Number: 21228659
• Product Code: KRB
• UDI-Device Identifier: 04250094500979
• UDI-Public: (01)04250094500979(17)290228(11)240301(10)800262
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K171620
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2025

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: PV2014L22-A
• Device Catalogue Number: 6885047
• Device Lot Number: 800262
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2025
• Supplement Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/04/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown