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 11/13/2022

Event Type  malfunction  

Manufacturer Narrative

Further information about the event has been requested.Investigation is ongoing.A supplemental emdr will be sent when the investigation is completed.Device not yet received.

Event Description

It has been reported that after puncture of the right femoral artery (without any problems), the seldinger wire of the picco catheter cannot be pushed out over the needle, at the end of the needle lumen it cannot be advanced or retracted.Removed the needle and wire as a whole and saw that the wire was split.No problems during puncture with new set.No harm or clinical consequences to patient or user have been reported.The indication for the use of picco was cardiogenic shock.The patient died a few days later in cardiogenic shock.With regard to the picco, there were no problems.Manufacturer reference #: (b)(4).

Manufacturer Narrative

It has been reported that after puncture of the right femoral artery (without any problems), the seldinger wire of the picco catheter cannot be pushed out over the needle, at the end of the needle lumen it cannot be advanced or retracted.Removed the needle and wire as a whole and saw that the wire was split.No harm or clinical consequences to patient or user have been reported.The indication for the use of picco was cardiogenic shock.The patient died a few days later in cardiogenic shock.The hospital confirmed that there has been no harm to the patient due to the guidewire issue.The guidewire has been returned still stuck inside the needle with approximately 0,5 cm of the guidewire tip sticking out of the front of the needle.During product inspection the justification for reporting could not be confirmed: a split of the guidewire as described by the customer could not be confirmed.The guidewire is complete; no uncoiling or parts separated could be detected.However it could be detected that the wire has a small kink on the tip in the area, which stuck out of the needle.Furthermore the j-tip is not in the original shape anymore (characteristic ¿j¿ is stretched) and is bent in a different direction.Kinks and an abnormal shape of the j-tip are indications of external force.It is not known what the customer meant by ¿split¿ as it could not be confirmed during product inspection.It cannot be excluded that the customer is referring to the kink and change in the shape of the j-tip.The ifu indicates to only use products if no sign of damage is visible: "do not use the catheter or accessories if any sign of product damage is visible." no defect (kink, j-typ with abnormal shape) has been reported before insertion.The hospital described that the guidewire could not be advanced further than the needle level, it has been blocked due to the guidewire split.This could not be confirmed during product inspection: - the guidewire tip was sticking out of the needle front with approximately 0,5 cm - the guidewire could be removed from the needle by further pushing it through the needle (insertion direction of guidewire).There was no indication for a resistance.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 (< 0,01 %, considering all types of picco catheters).The exact root cause could not be clarified.Based on the provided information and investigations the most probable root cause for the guidewire deformation is seen in a handling error or procedural issue during guidewire insertion.One potential scenario is that the needle has been introduced not in a flat angle or partly withdrew the guidewire against the needle bevel and the guidewire got stuck on the needle bevel.This could have caused the deformation of the guidewire.Additionally, it could result in the impossibility of further insertion.The ifu indicates: "warning: do not withdraw guide wire against needle bevel to avoid possible severing or damage of guide wire.¿ and "caution: make sure that the introducer cannula is introduced in a fl at angle (less than 45°)." according to the hospital, when the issue occurred, they had withdrawn the guidewire together with the needle without problems.This is in alignment with the applicable instruction for use.Also, this statement could be confirmed during product inspection as the guidewire has been returned still stuck in the needle.The user worked in alignment with the instruction for use, when problems have been encountered.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 guidewire is complete, neither uncoiled nor are parts separated.No harm or clinical consequences occurred.A kinked guidewire is not likely to result in death or serious injury and therefore does not fulfil the requirements of a reportable event.The accessory guidewire is supplied in the product picco catheter.The procedure to insert a catheter (¿seldinger technique¿) is well known for the healthcare professionals.The issue is monitored on a regularly basis in order to detect early trends.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.

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: 16012076
• MDR Text Key: 306545230
• Report Number: 3003263092-2022-00016
• Device Sequence Number: 1
• Product Code: KRB
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 02/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• 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: 706551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 60 KG