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

Model Number PV2015L20-A

Device Problem Material Fragmentation (1261)

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

Event Date 06/23/2023

Event Type  malfunction  

Manufacturer Narrative

It has been reported, that during the puncture of the right brachial artery under sonographic control.The insertion of the seldinger wire and passage over cannula was not possible.The wire penetrates only about 1.5-2cm.It was difficult to remove the guidewire.The guidewire has been uncoiled.The guide wire was available for in-house investigation.An uncoiling of the guide wire as described by the customer could be confirmed.The guide wire shows an uncoiling and a tapering at the wire tip, which is due to the use of excessive force.No severed parts could be detected.The tip of the guide wire was still attached to the wire.The instructions for use state to use the products only when no signs of damage are visible: "warning: do not use the catheter or accessories if damage to the product is externally of the product is externally visible." no defect (kink, j-type with abnormal shape) was reported before insertion.Upon further examination, bending was noted on the catheters' cannula, which was clear evidence of excessive force.A review of the manufacturing file did not reveal any deviations relevant to the reported problem.And therefore, a production error can be excluded.Additionally, we have not received any other complaints for this batch.This confirms the conformity of the product.Considering the very low complaint rate (< 0.01%, considering all picco catheter types), there is no indication of a systematic cause, such as design, production, material defects or others.The exact root cause could not be determined.Based on the available information and investigations, the most likely cause for the guide wire deformation is considered to be an application error or a procedural error during guide wire insertion.One possible scenario is that the needle was not inserted at a shallow angle, or the guidewire was partially retracted against the beveled tip of the needle and the guidewire became caught on it.This could have caused the guide wire to deform.In addition, this could have resulted in an inability to insert further.The hospital described that the guidewire could be inserted approximately 1.5 - 2 cm and did not penetrate the patient.The instructions for use state, "warning: when pulling out the guide wire, make sure it does not come into contact with the beveled tip of the needle, as the guide wire could be severed or damaged." and "caution: make sure the puncture needle is inserted at a shallow angle (less than 45°)." according to the hospital, the guide wire was difficult to pull out of the cannula.The applicable instructions for use state: "warning: when pulling out the guide wire, make sure that it does not come into contact with the beveled tip of the needle, as the guide wire could be severed or damaged.Another assumption of the hospital was that damage may have occurred during the puncture of the obese patient.This assumption was confirmed, as there was bending of the cannula.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 being used in a patient for advanced hemodynamic monitoring.The guidewire is complete, and no parts have separated; however, uncoiling of the guidewire is present.No patient harm or clinical consequences to the patient have occurred.The hospital stated that the guide wire could be inserted approximately 1.5 - 2 cm and did not penetrate the patient.The guide wire is used to insert the catheter for hemodynamic monitoring.The guide wire is an accessory in the picco catheter product.The insertion procedure "seldinger technique" is widely known in the medical community.This type of incident is regularly monitored to detect a negative trend as early as possible.Currently, no trend has been identified for this incident, therefore no additional actions will be initiated.Overall, 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.

Event Description

It has been reported, that during the puncture of the right brachial artery under sonographic control.The insertion of the seldinger wire and passage over cannula was not possible.The wire penetrates only about 1.5-2cm.It was difficult to remove the guidewire.The guidewire has been unraveled.Total wire completely removed at the end.No harm or clinical consequences to patient or user have been reported.Manufacturer reference #: (b)(4).

Event Description

Manufacturer reference: (b)(4).

Manufacturer Narrative

Correction of data due to modified interpretation: g4: from 06/28/2023 changed to 06/26/2023.

• 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: 17649848
• MDR Text Key: 322265996
• Report Number: 3003263092-2023-00007
• Device Sequence Number: 1
• Product Code: KRB
• UDI-Device Identifier: 04250094500931
• UDI-Public: (01)04250094500931
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2023
• 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
• Device Lot Number: 721352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2023
• Date Manufacturer Received: 06/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1