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

Catalog Number PV-2014L22-A

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/19/2019

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.Waiting for product return.

Event Description

It was reported that during retraction of the guidewire, resistance was met and the guidewire become uncoiled.No clinical consequences or harm to the patient occurred.No parts remained in patient.Manufacturer reference #: (b)(4).

Manufacturer Narrative

Investigation results indicate that a wrong batch number and catheter type was provided.The reported batch number does not match with the dimensions of the complained returned guidewire.Based on this information it could be concluded that not a catheter type pv2015l20-a was used as reported, but a pv2014l22-a.The concerned batch could not be provided by the customer.The returned guidewire was investigated under the microscope.It could be determined that the guidewire was not complete.The j-tip and the wire on the j-tip side were missing.It cannot be excluded that the parts become lost during the packaging or transportation procedure.The microscopic investigation revealed that the surface of the fracture of the guidewire core is rough with a diminution of the material.Additionally the guidewire showed some kinks.This is an indication that excessive force was used during the retraction procedure.This is supported by information provided by the customer.No problems could be encountered during puncturing and inserting of the guidewire.The complaint rate of similar complaints considering all kind of picco catheters is low ((b)(4)).A review of the dhr could not be performed for the involved catheter as the lot number could not be provided.Potentialy relevant batches have been reviewed.It could not identify any non conformities or deviations relevant to the reported issue.The picco technology is used for advanced hemodynamic monitoring.Based on the information provided by the customer and the investigation results it is considered as unlikely that the device did not meet its specifications.The root cause is seen in a handling error by the user, 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.¿.

Event Description

Manufacturer reference # (b)(4).

• 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: 9328267
• MDR Text Key: 205343868
• Report Number: 3003263092-2019-00019
• Device Sequence Number: 1
• Product Code: KRB
• UDI-Device Identifier: 04240094400931
• UDI-Public: (01)04240094400931(17)230331(10)643477
• 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: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: PV-2014L22-A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 12/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 103