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

Catalog Number PV2013L07N

Device Problems Entrapment of Device (1212); Material Fragmentation (1261); Difficult to Insert (1316)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/03/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Further information surrounding the event has been sought.The involved guidewire and the removed parts were discarded by the user.Investigation is ongoing at the moment.A supplemental medwatch report will be sent when the investigation is completed.(b)(4).

Event Description

It was reported that during insertion of the catheter with the guidewire, difficulties were observed.The guidewire was removed with no apparent signs of fracture, and new catheter was inserted in another arterial site.During x-ray for a preventive measure on (b)(6) 2017, foreign parts in the body were detected.On (b)(6) 2017, the foreign parts were removed by a surgical procedure and were identified as fragments of the catheter guidewire.No complication derived from the catheter placement was observed, and the patient recovered satisfactorily after removal of guidewire fragments.Manufacturer reference # : (b)(4).

Manufacturer Narrative

The involved guidewire and the removed parts were discarded by the user.Two other guidewires of the same batch were provided for investigation.During investigation of the two returned not-involved samples, no deviations from specification potentially causing the reported issue could be detected.A review of the dhr could not identify any non-conformities or deviations relevant to the reported issue.Considering the fact that the guidewire was fragmented into 4 parts, as shown on the provided x-ray, it is considered as most likely that the user has tried several times to withdraw the guidewire against the cannula.Withdrawing a guidewire against the cannula indicates a handling error by the user not following the ifu, as the ifu indicates (page 6): ¿do not withdraw guide wire against needle bevel to avoid possible severing or damage of guide wire.¿.(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: 6352858
• MDR Text Key: 68132554
• Report Number: 3003263092-2017-00001
• 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: company representative,distri
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 04/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PV2013L07N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 02/03/2017
• Date Device Manufactured: 02/01/2015
• 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
• Patient Age: 7 MO