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

Model Number PV2014L22-A

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/27/2022

Event Type  Injury  

Manufacturer Narrative

Further information about the event (incl.Lot number and patient data) has been requested.Investigation is ongoing.A supplemental emdr will be sent when the investigation is completed.Product not yet received.

Event Description

The following has been reported: as the guidewire was withdrawn through the cannula, the guidewire was split.No harm or clinical consequences for patient or user have been reported.Manufacturer reference #: (b)(4).

Manufacturer Narrative

Further information about the event (incl.Lot number and patient weight) has been requested.Investigation is ongoing.First product inspection indicates that the guidewire is not complete.The hospital has been informed about this issue.According to provided information the patient did not have significant narrowed/calcified arteries.The patient´s general sickness (not related to the event) was septic shock with hemodynamic instability.A supplemental emdr will be sent when the investigation is completed.H3 other text : device received, inspection currently ongoing.

Event Description

No problems have been encountered during insertion of the guidewire.But the guidewire could only be withdrawn against resistance.Manufacturer reference: #(b)(4).

Manufacturer Narrative

It has been reported that as the guidewire was withdrawn through the cannula, the guidewire was split.No problems have been encountered during insertion of the guidewire.But the guidewire could only be withdrawn against resistance.A new catheter has been placed with a new, non defective guidewire.Only the guidewire has been returned.Inspection of the returned product has been performed.The microscopic inspection revealed that the guidewire has not only been split on one end, but it has also been torn off: the surrounding wire has been torn off on one end and a part of the tip of the wire is missing.The missing tip has not been returned with the guidewire.The length estimation of the guidewire concluded in a length of 26-28 mm (33-37 mm according to specification).Therefore, the missing part is considered to have a length of 5-11 mm.The hospital has been informed about the inspection result.The hospital confirmed that no parts remained in the patient.Diagnostics were carried out on the patient during a vascular consultation using imaging.Imaging is understood as x-ray and therefore considered as medical intervention as a preventive measurement to prevent permanent injury.No further harm or clinical consequences have been reported.The case has been changed from a malfunction to a serious injury report.The affected lot number has not been provided by the hospital.A dhr review of relevant lot numbers 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 and investigation the root cause is seen in a handling error by the user by withdrawing the guidewire against the needle bevel.According to the problem description "as the guidewire was withdrawn through the cannula, the guidewire was split" and "no problems have been encountered during insertion of the guidewire.But the guidewire could only be withdrawn against resistance.".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.¿ it is not known if the needle has been inserted in a flat angle.The ifu states: "caution: make sure that the introducer cannula is introduced in a flat angle (less than 45°)." according to the customer, the patient had no significant narrowed or calcified arteries, which could have contributed to the event.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 intended user group are trained health care professionals who are used to handling of arterial lines.The seldinger technique is a standard procedure for intended users and is also described in the instructions for use.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

Only the guidewire has been returned.Inspection of the returned product has been performed.The microscopic inspection revealed that the guidewire is not complete.The hospital has been informed about the inspection result.The hospital confirmed that no parts remained in the patient.Diagnostics were carried out on the patient during a vascular consultation using imaging.Imaging is understood as x-ray and therefore considered as medical intervention as a preventive measurement to prevent permanent injury.No further harm or clinical consequences have been reported.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: 15822640
• MDR Text Key: 303928848
• Report Number: 3003263092-2022-00011
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2022
• 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: NOT PROVIDED.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 02/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male