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

Model Number	PV2015L20-A
Medical Device Problem Codes	Stretched (1601); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It has been reported that the after rejection of the puncture needle the guidewire appeared uncoiled.
Additional Manufacturer Narrative
Further information about the event has been requested.Device requested for investigation.A supplemental emdr will be sent when the investigation is completed.
Additional Manufacturer Narrative
We have completed our investigation of customer complaint #(b)(4).Problem description: it has been reported that during withdrawal of the puncture needle the guidewire was still attached to the needle.Investigation results: the device has been returned for an investigation.A visual check could confirm the described issue.A kink at the j-tip end of the guidewire was visible.This kind of damage has been intensively investigated in the past by the r&d department and could be traced back to a withdrawal of the guidewire against the cannula.Therefore, the root cause is seen in user error in operational context.A kinked guidewire is not likely to result in death or serious injury.Additionally, design changes of the guidewire (like stainless steel instead of nitinol and welding of tip instead of gluing) have been discussed to decrease the risk of breaking, uncoiling and kinking.But overall, no reasonable design change of the guidewire could be identified.All discussed changes would introduce new risks or increase existing risk, which would not be outweighed by the benefits.Overall, investigations did indicate that the device failed to meet its specification when the event occurred.A relationship between the device and the complaint is therefore considered as likely.Upon the complaint occurrence the device was involved and used on a patient for advanced hemodynamic monitoring.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 root cause).Based on the information stated above, no additional actions will be taken.The complaint will be closed.
Event or Problem Description
Manufacturer reference # (b)(4).

• 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: 20333126
• Report Number: 3003263092-2024-000002
• Device Sequence Number: 21230531
• Product Code: KRB
• UDI-Device Identifier: 04250094500931
• UDI-Public: (01)04250094500931(17)270930(11)221013(10)721356
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K171620
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PV2015L20-A
• Device Catalogue Number: 6885049
• Device Lot Number: 721356
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2024
• Supplement Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Patient Sex: Unknown