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 04/29/2021

Event Type  malfunction  

Manufacturer Narrative

Further information about the event has been requested.The reporting is based on the provided picture.The picture indicates an uncoiled guidewire, but due to the poor quality it can not be confirmed.Investigation is ongoing.A supplemental emdr will be sent when the investigation is completed.Device not returned.

Event Description

It has been reported that there is a non conformity related to fracture of the picco arterial catheter insertion guide.The provided picture indicates that the guidewire uncoiled.No harm or clinical consequences have been reported.Manufacturer reference: #(b)(4).

Manufacturer Narrative

Further information about the event has been received, see b5 "describe event or problem".Investigation is ongoing.A supplemental emdr will be sent when the investigation is completed.H3 other text : investigation not yet finalized.

Event Description

The customer confirmed that the guidewire is uncoiled.Picco monitoring installation has been performed.During the catheter insertion procedure, at the time of removing the guidewire, it presented difficulty.According to the operator's description, it "gets stuck" and when it has been removed, changes in its structure were observed.There have been no signs that a part of the guidewire is missing.No harm or clinical consequences occurred for the patient.Manufacturer reference: #466131.

Manufacturer Narrative

Further information has been provided by the customer: when removing the guidewire difficulties have been encountered.According to the operator's description, it "gets stuck" and when it has been removed, changes in its structure were observed.The guidewire has been returned for investigation.A visual check showed that the guidewire core was broken on the side of the j-tip and the wire uncoiled.The two parts of the broken guidewire core were fixated by the surrounding uncoiled wire.The tip is still intact, only the core of the guidewire was torn apart.Based on that, it can be concluded that the guidewire is still complete.This is supported by the customer´s observation.The other end of the guidewire did not show any deviation.A rejuvenation of the guidewire core could be detected on the surface of the broken core end.A rejuvenation is an indication for the use of excessive force.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 and a 100% control is performed during production.A guidewire of the same type (different batch) has been tested before, but no deficiency could be detected.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 investigation results (rejuvenation of fracture surface and guidewire uncoiling) the root cause for the uncoiling is seen in a handling error by the user.It is considered as likely that strong force has been used, when the guidewire got stuck.The ifu indicates: ¿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.¿ 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: ¿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.¿ according to the customer, it has not been known if the patient had stenosis or calcifications.Additionally, a correct insertion angle (< 45°) of the cannula ensures that the guidewire can be advanced and removed without difficulty.Instructions for proper handling of the cannula and guidewire is provided in the instructions for use: "caution: make sure that the introducer cannula is introduced in a fl at angle (less than 45°)." and "warning: do not withdraw guide wire against needle bevel to avoid possible severing or damage of guide wire." 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 and is state of the art.The procedure to insert a catheter (¿seldinger technique¿) is common knowledge 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.Based on this, 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
• MDR Report Key: 11861490
• MDR Text Key: 253149665
• Report Number: 3003263092-2021-00009
• Device Sequence Number: 1
• Product Code: KRB
• UDI-Device Identifier: 04250094500931
• UDI-Public: (01)04250094500931(17)250531(11)200624(10)679302
• Combination Product (y/n): N
• PMA/PMN Number: K171620
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 07/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2021
• 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: 679302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2021
• Date Manufacturer Received: 07/06/2021
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 75