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

Model Number PV2015L20-N

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

Patient Problems Hemorrhage, Cerebral (1889); Paresis (1998); No Code Available (3191)

Event Date 03/24/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Further information surrounding the event has been sought but not yet received.A supplemental medwatch report will be sent when the investigation is completed.

Event Description

The patient had a cerebral hemorrhage and during recovery, he had a picco-catheter inserted.After some weeks, the patient left the hospital.After approximately one year, the patient suddenly lost his voice and the examination at the doctor¿s office showed a lateral recurrens paresis.Later on, x-ray presented a guidewire on its way out of a.Carotids, pushing on the n.Recurrent on the left side.The guidewire was removed and the patient is now healthy.(b)(4).

Manufacturer Narrative

The involved guidewire was returned for investigation.During our investigation, the dimensions of the guidewire were measured and compared with a reference guidewire of pulsion medical systems.As the returned guidewire does not meet the specifications of a guidewire from pulsion medical systems se in length, but the positioning of the coating matches, it can be assumed that is likely the returned guidewire is a picco guidewire manufactured by pulsion medical systems.The root cause for the missing ends could not be determined.As the guidewire was left inside the patient more than 22 months and not withdrawn right after final placement of the catheter according to the instructions for use (ifu), this is seen as an user error.A dhr review could not be performed as no batch number was provided.(b)(4).

Event Description

Additional description of event : picco catheter was inserted into the patient on (b)(6) 2012 and withdrawn the day after, on (b)(6) 2012.During the spring of 2014, the patient experienced progressively increasing hoarseness.On (b)(6) 2014 the guidewire (used for the insertion of the catheter) was surgically removed through incision on the left side of the patient's throat.(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 85622 ; GM 85622
• Manufacturer (Section G): CORINNA VOLL; pulsion medical systems se; hans-riedl-str. 21; 85622 feldkirchen 85622 ; GM 85622
• Manufacturer Contact: pulsion medical systems se; hans-riedl-str. 21; 85622 feldkirchen 85622 ; 0498945991
• MDR Report Key: 5117103
• MDR Text Key: 27221485
• Report Number: 3003263092-2015-01001
• Device Sequence Number: 1
• Product Code: KRB
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K072364
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PV2015L20-N
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/16/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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