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

Model Number PV2014L22-A

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/20/2022

Event Type  Injury  

Manufacturer Narrative

Further information about the event (incl.Patient data) has been requested.Investigation is ongoing.A supplemental emdr will be sent when the investigation is completed.

Event Description

It has been reported that part of the catheter tip from the guide wire remained in the patient's vessel and had to be removed.Manufacturer reference: (b)(4).

Manufacturer Narrative

Further investigation is ongoing.A supplemental emdr will be sent when the investigation is completed.H3 other text : device not yet received.

Event Description

Further information surrounding the event has been received: during a picco insertion of the left femoral artery on 20.10.2022, a foreign body of about 2 cm in size detached from the guidewire and remained intracorporeally.In the angiological consultation with sonography, the foreign body was found to be located directly proximal to the bifurcation of the left femoral artery.In consultation with our in-house interventional radiologist, endovascular foreign body removal was performed.The issue has been detected when inserting the guidewire and withdrawing the needle.It has been tried to place the guidewire on both sides via seldinger technique.The vascular condition was bad.The guidewire was "slid back and forth".The patient died due to sepsis.The hospital confirmed that there is no connection to the picco catheter issue.Manufacturer reference: # (b)(4).

Manufacturer Narrative

It has been reported that part of the catheter tip from the guide wire remained in the patient's vessel and had to be removed.The issue has been detected when inserting the guidewire and withdrawing the needle.It has been tried to place the guidewire on both sides via seldinger technique.The patient died due to sepsis.The hospital confirmed that there is no connection to the picco catheter issue.Only the guidewire has been returned.Inspection of the returned product has been performed.The microscopic inspection revealed that the guidewire has been separated at one side and a small part of the guidewire tip is missing.Additionally, not only a part of the guidewire has been shared of.But the complete wire has been torn off on the same side (the wire is connected with the guidewire on two locations).A length estimation indicated that the missing tip of the guidewire has a length of approximately 6-16 mm.This is in alignment with feedback from the customer (a piece of around 2 cm has been removed from the patient).The needle has not been returned, therefore it is not possible to determine if the used needle had any malfunction or any deviation from the specification that could have contributed to the incident.A dhr review did not reveal any non conformity or deviation from specification which could have contributed to the event.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 provided information, investigations and experience the root cause is seen in a handling error by the user by withdrawing the guidewire against the needle bevel supported by the difficult vascular situation of the patient.Withdrawing against the needle, ultimately led to an excessive force, which resulted in the overcoming of the breaking point of the guidewire core and a fracture.The ifu indicates:¿warning: do not withdraw guide wire against needle bevel to avoid possible severing or damage of guide wire.¿ this is supported by information provided from the hospital that the vascular condition was bad and the guidewire was "slid back and forth".Overall, investigations did no indicate that the device failed to meet its specification when the event occurred.There is also no indication for a weakness of the supporting instruction for use.Patient factors such as vascular anomalies or pathological vascular processes may present difficulties in gaining vascular access such as problems with advancing or removing the guidewire.In this case, the customer provided information that the patient had narrowed/calcified arteries and the vascular condition was bad.The ifu indicates: "picco catheters are not intended for any use other than which is indicated.The catheter may not be used in patients where the placement of an indwelling arterial catheter is contraindicated e.G.In the case of arterial prostheses, insufficient perfusion or tissue damages around the puncture site as well as severe peripheral vascular diseases.A picco catheter should only be used if the expected results are reasonable in comparison to the risks." upon the event occurrence the device was involved and catheter insertion procedure on a patient for advanced hemodynamic monitoring was ongoing.The accessory guidewire is supplied in the product picco catheter.The procedure to insert a catheter (¿seldinger technique¿) is well known for healthcare professionals.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: christina carlsohn ; hans-riedl-strasse 17; feldkirchen 85622 ; GM 85622 ; 0894599140
• MDR Report Key: 15860404
• MDR Text Key: 304280504
• Report Number: 3003263092-2022-00013
• Device Sequence Number: 1
• Product Code: KRB
• UDI-Device Identifier: 04250094500979
• UDI-Public: (01)04250094500979
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K171620
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 01/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PV2014L22-A
• Device Catalogue Number: 6885047
• Device Lot Number: 698867
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Weight: 100 KG