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

Model Number PV2015L20-A

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/12/2023

Event Type  Injury  

Manufacturer Narrative

Manufacturer reference: # (b)(4).

Event Description

During insertion of a femoral picco arterial line using the seldinger technique it was noticed that the guide-wire was faulty.On removal the wire had separated and a 10cm section of fine wire had broken off-likely inside the patient.

Manufacturer Narrative

It has been reported that the guidewire had been broken and a 10cm section of the guidewire remained inside the patient.A provide picture showed a uncoiled guidewire.After several failed attempts to send the device for evaluation, a retained sample was investigated visually.The retained sample of the same lot (722789) was visually analyzed.No deviation could be detected.A dhr review did not reveal any non conformity or deviation from specification which could have contributed to the event.There is no indication for a systematic root cause as a deficiency of design, production or material considering the very low complaint rate (< 0,01 %, considering all types of picco catheters).One similar complaint has been received, reporting a guidewire separation and remaining parts in the patient.Unfortunately, the product in question was not available for analysis.Therefore, it is not possible to determine whether the device has failed to meet its specifications when the event occurred.Considering worst case scenario, a relationship between the device and the complaint is therefore considered as likely.Information indicates that upon the complaint occurrence the device was involved and used on a patient for advanced hemodynamic monitoring.Upon the event occurrence the device was involved and catheter insertion procedure on a patient for advanced hemodynamic monitoring was ongoing.The accessory guidewire is supplied in the product picco catheter.The procedure to insert a catheter (¿seldinger technique¿) is well known for healthcare professionals.The issue is monitored on a regularly basis in order to detect early trends.As there is no trend for this kind of issue no additional actions will be taken.With the information stated above the complaint will be closed.Correction: of udi from (b)(4).

Event Description

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: diana kitschke ; hans-riedl-strasse 17; feldkirchen 85622 ; GM 85622 ; 0894599140
• MDR Report Key: 18485193
• MDR Text Key: 332565101
• Report Number: 3013876692-2024-00002
• Device Sequence Number: 1
• Product Code: KRB
• UDI-Device Identifier: 04250094500938
• UDI-Public: (01)04250094500938
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K171620
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PV2015L20-A
• Device Catalogue Number: 6885049
• Device Lot Number: 722789
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/16/2024
• Distributor Facility Aware Date: 04/10/2024
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/16/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/10/2024
• Supplement Dates Manufacturer Received: 04/10/2024
• Supplement Dates FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/07/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention