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

Catalog Number PV2014L22-A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Infarction, Cerebral (1771)

Event Date 03/22/2020

Event Type  Injury  

Manufacturer Narrative

Further information surrounding the event has been requested and investigation is ongoing.A supplemental emdr will be sent when the investigation is completed.Product not returned.

Event Description

Patient hospitalization on (b)(6) 2020.Picco catheter has been placed brachial on (b)(6) 2020 to monitor patient with picco technology.On (b)(6), amputation due to lower limb necrosis, possibly due to severe burns.According to provided information no relation between picco catheter placement and amputation.On (b)(6) 3 p.M., cerebral infarction.(spontaneous breathing is lost.The next day, confirmed at ct).Patient has not been medicated with heparin.No further information provided about current status of patient.On the basis of the provided information it is not known if the use of the picco catheter has contributed to the cerebral embolism.Manufacturer reference #: (b)(4).

Manufacturer Narrative

The information provided by the physician stated that there is no relationship between the amputation and the use of the picco catheter.No batch number could be provided.A review of the dhr of all applicable batches could not identify any non-conformity or deviation from specification relevant to the reported issue.A similar catheter with greater length was tested in 2016 for its haemocompatibility.The results show that the requirements for the interaction of the test item with blood according to the applicable iso 10993-4 are fulfilled.Complaint trending does not point to a systematic manufacturing or design issue: the appearance rate of similar complaints (considering all types of picco catheter) is very low compared to the catheters sold within the last 3 years.The frequency of incidents in association with a picco catheter known to us is far below the published average of complications with arterial catheters.An investigation of a retain sample of another batch did not show any deviation from specification.The involved catheter was not sent in as it was discarded by the user.Therefore it is not possible to determine if the used catheter had any malfunction or any deviation from the specification that contributed to the event.On the basis of the provided information it cannot be fully clarified if the picco catheter contributed to the occurrence of the cerebral embolization.In general, the insertion of any foreign body into the human body can support an embolization.Considering all provided information the most probable root cause is seen in a known complication during arterial cannulation supported by the patient status (severe burn with amputation) and the avoidance of supporting medication (heparin).It is not known why no heparin has been used.This conclusion is supported by later provided information: the responsible physician does not think that the picco catheter is the cause for the cerebral infarction.No further information surrounding the event could be gathered due to covid-19 despite extensive effort.The instructions for use states possible complications during arterial cannulation.The issue will be further monitored on the market in order to identify trends.The picco technology is used for advanced hemodynamic monitoring.

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: 9957221
• MDR Text Key: 188644497
• Report Number: 3013876692-2020-00021
• Device Sequence Number: 1
• Product Code: KRB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 05/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PV2014L22-A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/13/2020
• Distributor Facility Aware Date: 05/13/2020
• Event Location: Hospital
• Date Report to Manufacturer: 05/13/2020
• Date Manufacturer Received: 05/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Disability