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

Catalog Number PV2015L20-A

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

Patient Problem Ischemia (1942)

Event Date 05/02/2019

Event Type  Injury  

Manufacturer Narrative

Further information has been requested and investigation is ongoing.A supplemental medwatch report will be sent when the investigation is completed.(b)(4).

Event Description

Acute ischemia in the leg after having placed picco catheter for 9 hours.The following actions have been taken: catheter removal, ct angiography, heparin and surgery with stent placement on artery dissection.No further clinical consequences occurred.Stabilized pathology and the patient is in good general condition.Manufacturer reference#: (b)(4).

Manufacturer Narrative

Correction- changed the pma/510(k)# to k171620 instead of k17120 as noted on the initial emdr.A supplemental medwatch report will be sent when the investigation is completed.Please note, getinge usa sales, llc(importer) is submitting the report on behalf of pulsion medical systems se (exemption number e2018007).Contact: (b)(6), 45 barbour pond road, wayne, new jersey 07470.

Event Description

Manufacturer reference#: (b)(4).

Event Description

Manufacturer reference#: (b)(4).

Manufacturer Narrative

Provided information by the customer is pointing out that the puncture itself caused the vascular dissection within the small vessel mentioned and was then migrated proximally towards the iliac artery where it became symptomatic (ischemia).The involved catheter was not available for investigation 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 incident.An investigation of a retain sample of the same batch and a dhr review could not be performed as the batch number was not provided.No similar complaints have been received for the catheter type pv2015l20-a within the last 3 years.A similar catheter with greater length was tested in june 2016 for its haemocompatibility.The results show that the requirements for the interaction of the test item with blood according to iso 10993-4 are fulfilled.The rate of complaints about any kind of ischemia in association with a picco catheter known to us is far below the published average of complications with arterial catheter.On the basis of the overall circumstances and the investigation results the most probable root cause is seen in a known complication of arterial cannulation.The instructions for use (ifu) have indications about the risk of the formation of an ischemia.The issue will be further monitored on the market in order to identify trends.

• Brand Name: PULSION PULSIOCATH THERMODILUTION CATHETERS
• Type of Device: PROBE, THERMODILUTION
• Manufacturer (Section D): PULSION MEDICAL SYSTEMS SE; hans-riedl-strasse 17; feldkirchen
• MDR Report Key: 8607570
• MDR Text Key: 144961147
• Report Number: 3003263092-2019-00006
• Device Sequence Number: 1
• Product Code: KRB
• Combination Product (y/n): N
• PMA/PMN Number: K171620
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 07/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PV2015L20-A
• Date Manufacturer Received: 07/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 57