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

Model Number PV2014L16-A

Device Problem Material Integrity Problem (2978)

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

Event Date 10/06/2023

Event Type  malfunction  

Manufacturer Narrative

Further information about the event has been requested.Device requested for investigation but discarded by user.A supplemental emdr will be sent when the investigation is completed.H3 other text : device requested but discarded by user.

Event Description

It was reported that, on (b)(6) 2023, due to gastrointestinal bleeding and unstable circulation in the patient, picco monitoring was planned to be performed.During the right femoral artery puncture and catheterization surgery, sterile disinfection and tissue laying were completed when checking the catheter and guide wire, it was found that the outer layer of the guide wire tip was disconnected and cannot be used, so the catheter was temporarily stopped.

Manufacturer Narrative

It was reported that the picco catheter pv2014l16-a guide wire tip was uncoiled before use on the patient.After the visual and subsequent microscopic examination of the 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.

Event Description

Manufacturer ref.: #(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: diana kitschke ; hans-riedl-strasse 17; feldkirchen 85622 ; GM 85622 ; 0894599140
• MDR Report Key: 18018689
• MDR Text Key: 326689503
• Report Number: 3003263092-2023-00010
• Device Sequence Number: 1
• Product Code: KRB
• UDI-Device Identifier: 04250094500962
• UDI-Public: (01)04250094500962
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2023
• 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: 708881
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Prefer Not To Disclose