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

Model Number	PV2015L20-A
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that while inserting the guidewire through the needle (pink) in a patient with severe arteriosclerosis, the guidewire got stuck in the chalk of the artery and when manipulating the guidewire through the needle, the tip was torn off.The doctor indicated that there was space between the needle and the guidewire and this, along with the arteriosclerosis which was a difficult procedure, may have been the cause of this incident.A ct scan was done to locate the guidewire , conclusion: the tip of the guidewire is still in the patient and located outside the artery.The patient and his family were informed.The patient will return soon for outpatient visit after admission to the icu.
Additional Manufacturer Narrative
Manufacturer reference: #(b)(4).
Event or Problem Description
Manufacturer reference # (b)(4).
Additional Manufacturer Narrative
It has been reported that the guidewire was torn off and parts remained inside the patient.Furthermore, it was reported that the patient had multiple arteriosclerosis and during the insertion the guidewire got stuck in the chalk of the artery.Upon withdrawal of the guidewire through the cannula, the tip of the guidewire was torn off.A ct scan showed that the guidewire tip remained in the patient outside the artery.If the guidewire has been removed is not known.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.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).One more similar complaint has been received, reporting a guidewire separation and remaining parts in the patient.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.¿ 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.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 or Problem Description
Manufacturer reference # (b)(4).
Additional Manufacturer Narrative
Accidently a follow-up report to the manufacturer report number: 3003263092-2023-00012 was send as malfunction.Therefore, as second follow-up is sent for correction as a serious injury was reported.

• Brand Name: PICCO CATHETER
• Common Device Name: 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: diana kitschke ; hans-riedl-strasse 17; feldkirchen 85622 ; GM 85622 ; 0894599140
• MDR Report Key: 18424503
• Report Number: 3003263092-2023-00012
• Device Sequence Number: 7771926
• Product Code: KRB
• UDI-Device Identifier: 04250094500931
• UDI-Public: (01)04250094500931(17)280229(11)230307(10)722789
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: PV2015L20-A
• Device Catalogue Number: 6885049
• Device Lot Number: 722789
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2023
• Supplement Date Received by Manufacturer: 03/20/2024; 04/23/2024
• Initial Report FDA Received Date: 01/02/2024
• Supplement Report FDA Received Date: 04/09/2024; 04/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Prefer Not To Disclose