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

Catalog Number PV2015L20-N

Device Problem Material Fragmentation (1261)

Patient Problem Embolus (1830)

Event Date 01/21/2014

Event Type  Injury  

Manufacturer Narrative

The reported picco catheter was returned for investigation.The reported problem was confirmed by microscopic inspection.A cut was found at 4.7 cm below the tip of the catheter together with a deformation of the material.The tip had been separated at exactly this point (to 2/3 by the cut and to 1/3 by the forces applied during removal of the guidewire with the dilator).According to our information a scalpel was used during removal of the dilator, so the cut can be explained by off-label-use of a scalpel (used with dilator in place) during application of the catheter.Please note, this event is being filed as a retrospective mdr as a result of a review of our complaint database.

Event Description

It was reported that during application of a picco catheter on a patient, the dilator could not be pulled out over the guide wire in place due to a high resistance and had to be removed together with the guide wire.After this it was noticed that the tip of the dilator had separated and had remained in the blood vessel from where it was transported with the blood stream further along the circulation.It finally got stuck in the knee artery (art poplitea), from where it had to be removed surgically.The final patient outcome was no injury.(b)(4).

• Brand Name: PULSION PULSIOCATH THERMODILUTION CATHETERS
• Manufacturer (Section D): PULSION MEDICAL SYSTEMS SE; feldkirchen ; GM
• Manufacturer Contact: volker humbert ; hans-riedl-str. 17; feldkirchen 85622 ; GM 85622 ; 9459914503
• MDR Report Key: 4994753
• MDR Text Key: 23064039
• Report Number: 3003263092-2015-00006
• Device Sequence Number: 1
• Product Code: KRB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K072364
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Report Date: 01/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PV2015L20-N
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/23/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2013
• 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): Required Intervention