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

Model Number	PV2014L22-A
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Further information about the event has been requested.Investigation is ongoing.A supplemental emdr will be sent when the investigation is completed.H3 other text : device not yet recieved.
Event or Problem Description
According to the user report from the federla institute for drugs an medical devices germany : when installing the above-mentioned catheter (pv2014l22-a, picco catheter 4f, 22cm, lot 708891), after inserting the guide wire, the dilator could not be threaded onto the nitinol seldinger wire due to resistance in the proximal lumen.The stenosis appears to be at the transition from the luer connector to the dilator shaft.By using a new set with a different dilator, the catheter could finally be placed.The procedure was prolonged as a result, and according to the current findings, no harm to the patient can be assumed.The catheter itself was preserved for the examination together with the dilator and nitinol-seldinger wire.
Additional Manufacturer Narrative
It was reported that the dilator could not be threaded onto the nitinol seldinger wire after inserting the guide wire due to resistance in the proximal lumen.No harm or clinical consequences occurred.The pv2014l22-a picco catheter was available for investigation.The problem reported could no be reproduced during functional check.The dilator could be shoved over the guidwire without noticeable resistance.The applicable instruction for use (ifu-lab-000151 vers.06) state: if applicable guide the dilator (4) in rotating motion over the guide wire (fig.E).Do not dilate the vessel wall.As there is no information on handling / use of the catheter a user error could not be excluded.It can be concluded,that a user error in a operational context could have let to the reported issue.A potential scenario could be a not performed rotating motion during guiding of the dilator over the guide wire.A dhr review did not reveal any non-conformities relevant to the reported issue.No further complaints have been received for this batch.There is no indication for a systematic root cause as a deficiency of design, production, material or other considering the very low complaint rate ((b)(4), considering all types of picco catheters).The exact root cause could not be confirmed as the reported problem could not be reproduced.Overall, the exact root cause could not be determined.The complaint investigation has been performed to the most possible extent.Upon the complaint occurrence the device was involved and used on a patient for advanced hemodynamic monitoring.The guide wire is used to insert the catheter for hemodynamic monitoring.The guide wire is an accessory in the picco catheter product.The "seldinger technique" insertion procedure is widely known among experts.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.At 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.Date of event according to customer: 07/27/2023.
Event or Problem Description
Manufacturer reference: #(b)(4).

• Brand Name: PICCO CATHETER
• Common Device Name: 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: 17642039
• Report Number: 3003263092-2023-00006
• Device Sequence Number: 20827797
• Product Code: KRB
• UDI-Device Identifier: 24250094500973
• UDI-Public: (01)24250094500973
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K171620
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2023

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
• Operator of Device: Health Professional
• Device Model Number: PV2014L22-A
• Device Catalogue Number: 6885047
• Device Lot Number: 708891
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2023
• Supplement Date Received by Manufacturer: 11/02/2023
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 11/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown