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

Model Number	PV2015L20-A
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2025
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 during insertion procedure guidewire uncoiled.No harm to patient reported to the date of submitting this report.Severed guide wire was retrieved without surgical intervention.Manufacturer reference # (b)(4).
Additional Manufacturer Narrative
Getinge received a customer complaint about a broken guide wire relating to the picco catheter.The investigation was performed in order to conduct analysis of that topic.On-site inspection and provided in record information confirmed the reported damaged catheter.The faulty guide wire was sent for further investigation.Visual inspection of the returned part confirmed the reported issue.There was no patient harm due to issue.The device failed to meet its specifications.The cause of the reported issue has not been determined.There is no indication for a systematic root cause as a deficiency of design, production or material.
Event or Problem Description
Manufactures reference id: (b)(4).

• 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): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna 85622 ; GM 85622
• Manufacturer Contact: caroline kabbabe ; roentgenvagen 2; solna 85622 ; GM 85622 ; 0894599140
• MDR Report Key: 22229218
• Report Number: 3003263092-2025-000000
• Device Sequence Number: 8691198
• Product Code: KRB
• UDI-Device Identifier: 04250094500931
• UDI-Public: (01)04250094500931(17)291031(11)241129(10)801109
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2025

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: PV2015L20-A
• Device Lot Number: 801109
• 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: 06/01/2025
• Supplement Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown