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

Model Number PV2014L16-A

Device Problem Material Twisted/Bent (2981)

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

Event Date 01/04/2024

Event Type  malfunction  

Event Description

The patient was in unstable hemodynamics and the doctor wanted monitoring picco.During the placement process, they found that it was difficult to insert the guide wire into the vessel via the cannula, the end was obviously bent, so they couldn't continue to operate.Then they opened another package of picco catheter to finish the process.

Manufacturer Narrative

Manufacturer reference: #(b)(4).H3 other text : device requested but discarded by user.

Manufacturer Narrative

It has been reported that it was difficult to insert the guide wire into the vessel via the cannula, the end was obviously bent, so the user couldn't continue to operate.Unfortunately, it is our understanding that the product in question is not available to be returned to us for analysis.Also, no pictures or videos provided by the customer.Therefore, the root cause cannot be determined.Nevertheless, a retained sample of the same lot was evaluated.No visual or microscopic deviation could be confirmed.A handling error by the user cannot be excluded.The ifu states: 1.Warning: kinks, bending or handling with a clamp can irreversibly damage the catheter.2.Caution: make sure that the introducer cannula is introduced in a fl at angle (less than 45°).3.Insert a part of the guide wire (3) through the cannula into the artery (fig.B).4.Warning: do not withdraw guide wire against needle bevel to avoid possible severing or damage of guide wire.5.Warning: if resistance is encountered when removing the guide wire, the guide wire could be kinked about tip of catheter within vessel (fig.K).In this case withdraw the catheter by 2 to 3 cm and try again to remove the guide wire.Use of excessive force may tear off the guide wire.Therefore, guide wire and catheter are to be removed simultaneously.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 root cause).Overall, it is not possible to define if the device failed to meet its specification when the problem occurred.A relationship between the device and the complaint is therefore considered, in worst case scenario, as likely.Information indicates that upon the complaint occurrence the device was involved and used on a patient for advanced hemodynamic monitoring.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.

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: 18757283
• MDR Text Key: 336972007
• Report Number: 3003263092-2024-00002
• Device Sequence Number: 1
• Product Code: KRB
• 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
• Report Date: 02/21/2024

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: PV2014L16-A
• Device Catalogue Number: 6885046
• Device Lot Number: 708879
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 02/07/2024
• Initial Date FDA Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/19/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: N/A.
• Patient Outcome(s): Other
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 61 KG