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

Catalog Number PV2014L16N

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

Patient Problems Embolism (1829); Gangrene (1873)

Event Date 11/26/2016

Event Type  Injury  

Manufacturer Narrative

Further information surrounding the event has been sought.It was reported that the involved catheter is not available for investigation, as it was thrown away by the user.Investigation is ongoing.A supplemental medwatch report will be sent when the investigation is completed.(b)(4).

Event Description

It was reported that a picco line was inserted into right brachial artery for cardiac output goal directed therapy.Approximately 12-14 hours after insertion, arm back cold, stiff and pale (despite anticoagulation at the time).Patient went to theatre for emergency embolectomy the following day and a 10 cm clot was retrieved.Resulted in non viable distal limb with gangrene and likely amputation.(b)(4).

Manufacturer Narrative

The involved catheter was not available for investigation, as it was thrown away 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.Additionally a retain sample from the same batch was investigated.No deviations with a pro-thrombotic effect could be detected.A similar catheter with greater length was tested in june of 2016 for its haemocompatibility.The results of the haemocompatibility tests reflected the good haemocompatibility of the tested item.A review of the dhr could not identify any non-conformities or deviations relevant to the reported issue.To our understanding and, after considering the patient conditions, the incident has to be seen as a known complication of arterial cannulation.The instructions for use (ifu) have several indications about the risk of thrombosis and embolism.(b)(4).

Event Description

(b)(4).

• Brand Name: PULSION PULSIOCATH THERMODILUTION CATHETERS
• Type of Device: PROBE, THERMODILUTION
• Manufacturer (Section D): PULSION MEDICAL SYSTEMS SE; pulsion medical systems se; hans-riedl-str. 21; 85622 feldkirchen ; GM
• Manufacturer (Section G): CORINNA VOLL; pulsion medical systems se; hans-riedl-str. 21; 85622 feldkirchen ; GM
• Manufacturer Contact: pulsion medical systems se; hans-riedl-str. 21; 85622 feldkirchen ; 0498945991
• MDR Report Key: 6195281
• MDR Text Key: 63027587
• Report Number: 3003263092-2016-00020
• Device Sequence Number: 1
• Product Code: KRB
• Combination Product (y/n): N
• PMA/PMN Number: K072364
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PV2014L16N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 12/07/2016
• Date Device Manufactured: 07/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 82 YR
• Patient Weight: 63