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

Model Number	PV2014L16-A
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/20/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 or Problem Description
(b)(4).
Additional 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
• Common Device Name: PROBE, THERMODILUTION
• Manufacturer (Section D): PULSION MEDICAL SYSTEMS SE; hans-riedl-strasse 17; feldkirchen 85622 ; GM 85622
• MDR Report Key: 9346684
• Report Number: 3003263092-2019-00020
• Device Sequence Number: 18906372
• Product Code: KRB
• UDI-Device Identifier: 04250094500962
• UDI-Public: (01)04250094500962(17)230731(10)644670
• 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: company representative,consum
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2019

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 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
• Initial Date Received by Manufacturer: 10/22/2019
• Supplement Date Received by Manufacturer: 12/23/2019
• Initial Report FDA Received Date: 11/20/2019
• Supplement Report FDA Received Date: 12/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 150