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

Model Number	PV2015L20-A
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Further information about the event and the health effect has been requested.Investigation is ongoing.A supplemental emdr will be sent when the investigation is completed.
Event or Problem Description
The following has been reported: today i had problems with the guide wire when pricking a picco line: when the guide wire could not be advanced, i wanted to retrieve it but it was stuck.I had to pull hard but couldn't move.Then the guide wire with needle and all removed.I have the feeling that there is no material left in the patient, but i am not 100% sure.Manufacturer reference: #(b)(4).
Additional Manufacturer Narrative
The guidewire and needle have been returned for investigation.During microscopic investigation it has been detected that one side of the guidewire is not complete as a small part of the tip is missing.The customer has been informed.Further information has been provided by the involved physician: the guidewire could not been inserted further.It was not possible to remove it in spite using some force.The guidewire with needle as a whole has been removed.The patient passed away less than 24 hours after the insertion of the picco-line.The customer stated with certainty that there has been no relation between the patient´s death and the placement of the picco-line.During the day no anomalies were seen on the leg.A dhr review did not reveal any non-conformities relevant to the reported issue.According to specification the guidewire shall withstand a tensile strength of 10 n.A 100% control is performed during production.The customer reported that some force has been used, but it was not possible to retract.This indicates that the guidewire was structurally whole and withstood a certain force before breaking.A root cause related to the production process is therefore considered as unlikely.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).Based on the information provided by the customer and the product investigation results (diminution of fracture surface and guidewire uncoiling) the root cause for the uncoiling and the separated part is seen in a handling error by the user.It is considered as likely that the guidewire was stuck on the needle bevel when retracting the guidewire.Strong force and withdrawing the guidewire against the needle could lead to a breaking and uncoiling.The instruction for use (ifu) indicates: "warning: do not withdraw guide wire against needle bevel to avoid possible severing or damage of guide wire." and ¿if resistance is encountered when removing the guide wire, the guide wire could be kinked about tip of catheter within vessel.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.¿ additionally, a correct positioning of the cannula bevel and a correct insertion angle (< 45°) of the cannula ensure that the guidewire can be advanced and removed without difficulty.No problems have been encountered when inserting a second catheter.It is not known why the guidewire got stuck during insertion procedure.But it cannot be excluded that patient factors contributed to the situation.Contraindications are stated in the ifu.Overall, investigations did no indicate that the device failed to meet its specification when the event occurred.Upon the event occurrence the device was involved and used on a patient for advanced hemodynamic monitoring.The accessory guidewire is supplied in the product picco catheter.The procedure to insert a catheter (¿seldinger technique¿) is state of the art for healthcare professionals.The issue is monitored on a regularly basis and during post market surveillance activities in order to detect early trends.
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: 11594791
• Report Number: 3003263092-2021-00005
• Device Sequence Number: 17022106
• Product Code: KRB
• UDI-Device Identifier: 04250094500931
• UDI-Public: (01)04250094500931(17)250430(11)200526(10)676086
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K171620
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2021

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: 04/30/2025
• Device Model Number: PV2015L20-A
• Device Catalogue Number: 6885049
• Device Lot Number: 676086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2021
• Initial Date Received by Manufacturer: 03/18/2021
• Supplement Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 03/31/2021
• Supplement Report FDA Received Date: 04/28/2021
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 86