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

Model Number PV2015L20-A

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/12/2023

Event Type  Injury  

Manufacturer Narrative

Manufacturer reference: # (b)(4).

Event Description

During insertion of a femoral picco arterial line using the seldinger technique it was noticed that the guide-wire was faulty.On removal the wire had separated and a 10cm section of fine wire had broken off-likely inside the patient.

• Brand Name: PICCO CATHETER
• Type of Device: 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: diana kitschke ; hans-riedl-strasse 17; feldkirchen 85622 ; GM 85622 ; 0894599140
• MDR Report Key: 18485193
• MDR Text Key: 332565101
• Report Number: 3013876692-2024-00002
• Device Sequence Number: 1
• Product Code: KRB
• UDI-Device Identifier: 14250094500938
• UDI-Public: (01)14250094500938
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K171620
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PV2015L20-A
• Device Catalogue Number: 6885049
• Device Lot Number: 722789
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/10/2024
• Distributor Facility Aware Date: 01/08/2024
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/10/2024
• Date Manufacturer Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/07/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention