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

Model Number PV2014L16-A

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/12/2023

Event Type  malfunction  

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 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needle, it was found that the guide wire entered the vascular end and was damaged after the needle was connected and withdrawn.Therefore, the guide wire was immediately replaced without causing any damage to the patient.Manufacturer reference: (b)(4).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 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needle, it was found that the guide wire entered the vascular end and was damaged after the needle was connected and withdrawn.Therefore, the guide wire was immediately replaced without causing any damage to the patient.Manufacturer reference: (b)(4).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
• 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: florian kopp ; hans-riedl-strasse 17; feldkirchen 85622 ; GM 85622 ; 0894599140
• MDR Report Key: 16982521
• MDR Text Key: 315759917
• Report Number: 3003263092-2023-00001
• Device Sequence Number: 1
• Product Code: KRB
• UDI-Device Identifier: 04250094500962
• UDI-Public: (01)04250094500962(17)260430(11)210526(10)694226
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K171620
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 07/13/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/26/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Sex: Male