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	10/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the picco catheter pv2014l16-a guide wire tip was uncoiled before use on the patient.After examination of the retain sample, no deviation or uncoiling of the guide wire could be determined.A dhr check did not identify any deviations or non-conformities related to the failure description.Overall, the investigations revealed no evidence that the product did not meet its specification at the time of the event.At the time of the event, the product was prepared to be used in a patient for advanced hemodynamic monitoring.The guidewire is complete, and no parts have separated; however, uncoiling of the guidewire is present as shown by the user.No patient harm or clinical consequences to the patient have occurred.The exact root cause could not be determined.The complaint investigation has been performed to the most possible extent and the hypothesis for justification of reporting could not be confirmed during investigation.The issue will be further monitored on the market to identify trends.With the information available, the incident is closed.H3 other text : device requested but discarded by user due to country specific regulations.
Event or Problem Description
During the process of inserting the catheter for the patient, the insertion guide wire was damaged, the external spring guide wire was loose, and it could not be inserted.The catheter failed to be inserted, and the catheter was re-inserted.No patient harm or clinical consequences to the patient have occurred.

• 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: diana kitschke ; hans-riedl-strasse 17; feldkirchen 85622 ; GM 85622 ; 0894599140
• MDR Report Key: 18273692
• Report Number: 3003263092-2023-00011
• Device Sequence Number: 14867607
• Product Code: KRB
• UDI-Device Identifier: 04250094500962
• UDI-Public: (01)04250094500962
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/05/2023

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 Model Number: PV2014L16-A
• Device Catalogue Number: 6885046
• Device Lot Number: 708882
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2023
• Initial Report FDA Received Date: 12/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/24/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Patient Sex: Unknown