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	Foreign Body In Patient (2687)
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It was reported that during placement of picco catheter the resistance was encountered, therefore the wire was withdrawn.During withdrawal, resistance was encountered along its course; the wire could neither be moved forward nor backward.The wire almost completely broke at the level of the pigtail, remaining connected to the tip of the pigtail only by a strand of wire approximately the thickness of a hair.Through an extended skin incision, it is possible to retrieve the tip of the seldinger wire, probably completely.Final patient outcome is unknown.Manufacturer reference # (b)(4).

• Brand Name: PICCO CATHETER
• Common Device Name: PROBE, THERMODILUTION
• Manufacturer (Section G): PULSION MEDICAL SYSTEMS SE; einsteinring 30; aschheim-dornach 85609 ; GM 85609
• Manufacturer Contact: nicole kammermaier ; einsteinring 30; aschheim-dornach 85609 ; GM 85609 ; 0894599140
• MDR Report Key: 24219514
• Report Number: 3003263092-2026-000000
• Device Sequence Number: 9365892
• Product Code: KRB
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2026

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: 6885049
• Device Lot Number: 801365
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2026
• Supplement Date Received by Manufacturer: 06/25/2026
• Initial Report FDA Received Date: 01/30/2026
• Supplement Report FDA Received Date: 06/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown