MAUDE Adverse Event Report: GETINGE USA SALES LLC 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	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It was reported that during placement of picco catheter the resistance was encountered, therefore the wire was withdrawn.During withdrawal, resistance was encountered along its course; the wire could neither be moved forward nor backward.The wire almost completely broke at the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).
Event or Problem Description
Manufacturer reference #(b)(4).
Additional Manufacturer Narrative
A picco catheter, in which it was reported that the guidewire became uncoiled and broke during retraction.The investigation was performed in order to conduct analysis of that topic.On-site inspection and provided in record information confirmed the reported damaged guide wire.The faulty guide wire was sent for further investigation.Visual inspection of the returned part confirmed the reported issue; the guide wire was uncoiled.The patient passed away later on the event date from pulmonary complications.There is no allegation from the clinical staff involved in the patient¿s care that the picco catheter or its insertion in any way caused or contributed to the patient¿s death there is no indication for a systematic root cause as a deficiency of design, production or material.Picco catheters are used as accessories for thermodilution and arterial blood pressure measurement.The are indicated in patients where cardiovascular and circulatory volume status monitoring is necessary.Such as patients in surgical, medical, cardiac and burn specialty units as well as other specialty units where cardiovascular monitoring is desired and patients are undergoing surgical interventions of such magnitude that cardiovascular monitoring is necessary.

• Brand Name: PICCO CATHETER
• Common Device Name: PROBE, THERMODILUTION
• Manufacturer (Section D): GETINGE USA SALES LLC
• 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 ; +049 0894599140
• MDR Report Key: 24222927
• Report Number: 3013876692-2026-00012
• Device Sequence Number: 8197013
• Product Code: KRB
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K171620
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2026
• Report Date (Section F): 06/29/2026

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
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 06/29/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/25/2026
• Initial Report FDA Received Date: 01/30/2026
• Supplement Report FDA Received Date: 06/29/2026
• 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
• Date Report Sent to FDA: 06/29/2026