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

Model Number	PV2015L20-A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2021
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.
Event or Problem Description
It has been reported that when the picco catheter pv2015l20-a was passed through the femoral artery, blood was seen coming out from the part that was outside the patient's skin, which is why it was necessary to request another input.Blood loss has been described as a "few drops".No harm or clinical consequences occurred.Manufacturer reference: #: (b)(4).
Additional Manufacturer Narrative
A retain sample of the same batch has been inspected but no deficiency could be detected during visual and functional testing.No similar complaints have been received for this batch.A dhr check could not identify any non-conformities or deviations relevant to the reported issue.A 100 % leak test is performed during production.Overall, it can be concluded that there is no indication for a systematic root cause as a deficiency of design, production or material due to the very low complaint rate (< 0,01 %, considering all types of picco catheters).A leakage in the blue intravascular tubing close to the channel separation has been confirmed based on the provided picture and video.The device has been discarded.Therefore, it is not possible to determine if the complained device had any deviations from specification or an user error occurred, which could have contributed or caused the event.The ifu states warnings in regards to leakage and damaging of the catheter: "warning: do not alter or cut the catheter, guide wire, or any other set component during insertion, use or removal." and "warning: kinks, bending or handling with a clamp can irreversibly damage the catheter.", "do not use the catheter or accessories if any sign of product damage is visible." the complaint investigation has been performed to the most possible extent.Upon the event occurrence the device was involved and used on a patient for advanced hemodynamic monitoring.No harm or clinical consequences occurred.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.H3 other text : device discarded by the hospital.
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
• MDR Report Key: 11788834
• Report Number: 3003263092-2021-00008
• Device Sequence Number: 19837857
• Product Code: KRB
• UDI-Device Identifier: 04250094500931
• UDI-Public: (01)04250094500931(17)240430(11)190506(10)662103
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K171620
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2021

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 Expiration Date: 04/30/2024
• Device Model Number: PV2015L20-A
• Device Catalogue Number: 6885049
• Device Lot Number: 662103
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/30/2021
• Supplement Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 05/07/2021
• Supplement Report FDA Received Date: 05/27/2021
• Patient Sequence Number: 1
• Patient Weight: 72