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

Model Number	PV2014L16-A
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/17/2025
Type of Reportable Event	Serious Injury
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 due to patient conditions picco technology was decided to be used.The insertion of needle proceeded smoothly.During guidewire insertion, significant resistance was encountered.The guidewire was subsequently withdrawn but met resistance.Upon removal of the puncture needle, it was discovered that the guidewire had become uncoiled and could not be retrieved.Due to patient's physical and medical condition prior to event, which might have contributed to adhesion or incarceration of the unwound guidewire within the vascular wall or surrounding tissues, it was decided need for surgical intervention to remove guidewire.The patient¿s state remained stable.Manufacturer reference # (b)(4).
Event or Problem Description
Manufacturer reference # (b)(4).
Additional Manufacturer Narrative
Guidewire uncoiled during retraction was reported.The puncture was performed without problem, with arterial blood return observed through the needle.However during guidewire insertion at approximately 5-7 cm, a resistance was encountered.Moreover, during the retraction the same resistance was observed.The guidewire could not be retrieved.The second surgery was necessary to retrieve the guidewire from patient's vessel.The vascular surgery department performed a bedside surgical procedure and completely removed the guidewire.Throughout the procedure, the patient's vital signs remained stable with advanced life support.No any further harm to the patient.Unfortunately, no pictures of the part were provided.The faulty part was not returned for in-house investigation and was discarded, 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.The issue is monitored on a regularly basis in order to detect early trends.As there is no trend for this kind of issue no additional actions will be taken.

• 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: 23433764
• Report Number: 3003263092-2025-000002
• Device Sequence Number: 18298947
• Product Code: KRB
• UDI-Device Identifier: 04250094500962
• UDI-Public: (01)04250094500962(17)280331(11)230425(10)729504
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PV2014L16-A
• Device Lot Number: 729504
• 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
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/25/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 70 KG