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

Model Number PV2015L20-A

Device Problems Material Fragmentation (1261); Material Integrity Problem (2978)

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

Event Date 03/11/2024

Event Type  malfunction  

Event Description

It has been reported that the guidewire uncoiled after preparation for advanced hemodynamic patient monitoring.The defect was noticed because the guidewire slid poorly through the plastic protective tube and then through the cannula.After finishing the installation of the picco catheter, it was noticed that the guidewire appeared as if the surface layer at both ends had disappeared.The customer was asked to send us the catheter for inspection, but no response has been received to date.

Manufacturer Narrative

H3 other text : device not yet recieved.

Manufacturer Narrative

It has been reported that the guidewire uncoiled after preparation for advanced hemodynamic patient monitoring.The defect was noticed because the guidewire slid poorly through the plastic protective tube and then through the cannula.After finishing the installation of the picco catheter, it was noticed that the guidewire appeared as if the surface layer at both ends had disappeared.No product and not lot was provided by the customer.Therefore a retain sample with a knwon lot was investigated.Overall, investigations did indicate that the device failed to meet its specification when the event occurred.A relationship between the device and the complaint, in worst case senario, is therefore considered as likely.The guidewire is complete, and no parts have separated; however, uncoiling of the guidewire was resulted.No patient harm or clinical consequences to the patient have occurred due to the reported issue.The death of the patient is related to poor neurological prognosis.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 will be closed.#d - device avail for eval corrected h3 other text : device not available for evaluation.

Event Description

N/a.

• 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: sevde karacabey ; hans-riedl-strasse 17; feldkirchen 85622 ; GM 85622 ; 0894599140
• MDR Report Key: 19030590
• MDR Text Key: 339204965
• Report Number: 3003263092-2024-00008
• Device Sequence Number: 1
• Product Code: KRB
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/13/2024

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
• Device Operator: Health Professional
• Device Model Number: PV2015L20-A
• Device Catalogue Number: 6885049
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/11/2024
• Initial Date FDA Received: 04/03/2024
• Supplement Dates Manufacturer Received: 05/10/2024
• Supplement Dates FDA Received: 05/14/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1