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

Model Number	PV2014L16-A
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Further information about the event has been requested.Supplemental emdr will be sent when the investigation is completed.H3 other text : device not yet received.
Event or Problem Description
Patients with septic shock require picco catheterization to monitor cardiac output use the v2014l16-a kit in the report; during femoral artery puncture, adjusting the guide wire when it was discovered that the guide wire was stuck in the puncture needle, it was found that the guide wire entered the vascular end and was damaged after the needle was connected and withdrawn.Therefore, the guide wire was immediately replaced without causing any damage to the patient.Manufacturer reference: (b)(4).
Event or Problem Description
Patients with septic shock require picco catheterization to monitor cardiac output use the v2014l16-a kit in the report; during femoral artery puncture, adjusting the guide wire when it was discovered that the guide wire was stuck in the puncture needle, it was found that the guide wire entered the vascular end and was damaged after the needle was connected and withdrawn.Therefore, the guide wire was immediately replaced without causing any damage to the patient.Manufacturer reference: (b)(4).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): PULSION MEDICAL SYSTEMS SE; hans-riedl-strasse 17; feldkirchen 85622 ; GM 85622
• Manufacturer Contact: florian kopp ; hans-riedl-strasse 17; feldkirchen 85622 ; GM 85622 ; 0894599140
• MDR Report Key: 16982521
• Report Number: 3003263092-2023-00001
• Device Sequence Number: 15166810
• Product Code: KRB
• UDI-Device Identifier: 04250094500962
• UDI-Public: (01)04250094500962(17)260430(11)210526(10)694226
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2023

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 Expiration Date: 04/30/2026
• Device Model Number: PV2014L16-A
• Device Catalogue Number: 6885046
• Device Lot Number: 694226
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2023
• Supplement Date Received by Manufacturer: 07/13/2023
• Initial Report FDA Received Date: 05/23/2023
• Supplement Report FDA Received Date: 07/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/26/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Sex: Male