MAUDE Adverse Event Report: PULSION MEDICAL SYSTEMS SE PULSION PULSIOCATH THERMODILUTION CATHETERS; PROBE, THERMODILUTION

Model Number PV2015L20-A

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/06/2019

Event Type  malfunction  

Manufacturer Narrative

Further information has been requested and investigation is ongoing.A supplemental emdr will be sent when the investigation is completed.Device has not been returned by the hospital.

Event Description

It was reported that during the placement of the picco catheter in the right femoral artery after the puncture of the artery, the guidewire was inserted through the needle.The guidewire itself could not be inserted for more than a few cm (length of the needle itself).It was immediately attempted to extract the guidewire without success; it was blocked.Needle and guidewire were removed at the same time and the guidewire was found to be damaged and the wire deformed.An uncoiled guidewire is regarded as a malfunction that could lead to a serious injury, if the malfunction is to recur.No harm or clinical consequences have been reported.(b)(4).

Event Description

Manufacturer reference #: (b)(4).

Manufacturer Narrative

The concerned guidewire has not been provided as it was discarded by the hospital; no pictures have been provided.Initial complaint description indicated that the guidewire was deformed: the customer assumed that the guidewire was uncoiled, which is considered as reportable case.As the product has not been returned it is not possible to determine if the used guidewire had any malfunction or any deviation from specification that could have contributed to the event.A retain sample from the same batch has been investigated but no deficiency could be detected during visual and functional testing.A dhr review did not reveal any non-conformities relevant to the reported issue.The ifu has indications to not use the product if signs of damage are visible.The complaint rate of similar complaints considering all kind of picco catheters is very low (<0,01 %).The picco technology is used for advanced hemodynamic monitoring.Based on the overall investigation results and experience, the most probable root cause is seen in a handling error by the user by withdrawing the guidewire against the cannula, as the ifu indicates: "do not withdraw guide wire against needle bevel to avoid possible severing or damage of guide wire." this is supported by information provided by the customer: "(.)an attempt was immediately made to extract the guide without success, it was blocked.The needle and guide were removed at the same time and it was found that the guide was damaged and that the spirals were deformed." it is not known if patient factors contributed to the situation.Contraindications are stated in the ifu that a picco catheter should only be used if the expected results are reasonable in comparison to the risks.The guidewire supplied in the product picco catheter is state of the art.As well as the procedure to insert a catheter (¿seldinger technique¿), which is well-known by healthcare professionals.The procedure is used for various types of catheters and not dependent on the picco technology.

• Brand Name: PULSION PULSIOCATH THERMODILUTION CATHETERS
• Type of Device: PROBE, THERMODILUTION
• Manufacturer (Section D): PULSION MEDICAL SYSTEMS SE; hans-riedl-strasse 17; feldkirchen 85622 ; GM 85622
• MDR Report Key: 9716692
• MDR Text Key: 221862352
• Report Number: 3003263092-2020-00001
• Device Sequence Number: 1
• Product Code: KRB
• UDI-Device Identifier: 04250094500931
• UDI-Public: (01)04250094500931(17)230930(10)660718
• Combination Product (y/n): N
• PMA/PMN Number: K171620
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: PV2015L20-A
• Device Catalogue Number: PV2015L20-A
• Device Lot Number: 660718
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 75