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

Model Number PV2014L16-A

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/20/2019

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 was discarded by the hospital.

Event Description

It was reported that when removing the metal guide, it frayed, and could not be removed from the plastic guide.Therefore, it was necessary to change the equipment.This occurred 4 times on the same batch, resulting in the requirement to bite the patient 4 times in arterial.No clinical consequences or harm to the patient occurred.(b)(4).

Event Description

(b)(4).

Manufacturer Narrative

The concerned guidewires have not been provided as they were discarded by the hospital; no pictures have been provided.Therefore 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; no similar complaints have been reported for this batch.Information provided by the customer explained that there was no initial malfunction of the guidewire as the guidewire and catheter could be inserted without any problems.The complaint rate of similar complaints considering all kind of picco catheters is low (<0,01 %).The picco technology is used for advanced hemodynamic monitoring.Based on the circumstances, investigation results and experience, the most probable root cause is seen in a handling error by the user by applying excessive force during retraction, as the ifu indicates: ¿if resistance is encountered when removing the guide wire, the guide wire could be kinked about tip of catheter within vessel.In this case withdraw the catheter by 2 to 3 cm and try again to remove the guide wire.Use of excessive force may tear off the guide wire.Therefore, guide wire and catheter are to be removed simultaneously.¿ the patient had a weight of more than 150 kg, it cannot be excluded that this factor has contributed to the event.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.Device has not been returned from the hospital as it was discarded.

• 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: 9346684
• MDR Text Key: 195400992
• Report Number: 3003263092-2019-00020
• Device Sequence Number: 1
• Product Code: KRB
• UDI-Device Identifier: 04250094500962
• UDI-Public: (01)04250094500962(17)230731(10)644670
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: PV2014L16-A
• Device Catalogue Number: PV2014L16-A
• Device Lot Number: 644670
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 12/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 150