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

Model Number PV2015L20-A

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Event 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.

Manufacturer Narrative

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: diana kitschke ; hans-riedl-strasse 17; feldkirchen 85622 ; GM 85622 ; 0894599140
• MDR Report Key: 18424503
• MDR Text Key: 331773830
• Report Number: 3003263092-2023-00012
• Device Sequence Number: 1
• Product Code: KRB
• UDI-Device Identifier: 04250094500931
• UDI-Public: (01)04250094500931(17)280229(11)230307(10)722789
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: Physician
• Type of Report: Initial
• Report Date: 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/03/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization