MAUDE Adverse Event Report: PULSION MEDICAL SYSTEMS SE PICCO CATHETER; PROBE, THERMODILUTION

Catalog Number PV2015L20-A

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/24/2019

Event Type  Injury  

Manufacturer Narrative

The concerned product and further information has been requested.The investigation is ongoing.A supplemental medwatch report will be sent when the investigation is completed.Product not yet returned.

Event Description

It was reported that during insertion of the picco catheter with the guidewire difficulties were observed (b)(6) 2019).Guidewire was removed and showed signs of fracture.A completely new set of picco catheter has been inserted without difficulties.Due to the patient´s critical condition x-ray and ct-angiography check could only be performed on (b)(6); a foreign part (3 cm) has been detected in the patient´s femoral artery.The foreign part has been removed on (b)(6).The patient´s status is stable.The thermodilution has been performed with the inserted picco catheter several times during the days without problems.Manufacturer reference #: (b)(4).

Manufacturer Narrative

The concerned product could not be provided by the customer, but the surgically removed part.The returned part was investigated and could be confirmed as a part of the guidewire core and partially uncoiled wire.The surface of the fracture of the guidewire core is rough with a rejuvenation and several parts of the wire showed kinks.The rough surface and rejuvenation is an indication that excessive force was used during the insertion procedure.Information provided by the customer confirmed that there was no initial malfunction of the guidewire as the guidewire could be inserted without any problems.The complaint rate of similar complaints considering all kind of picco catheters is low (<0,01 %).A review of the dhr could not be performed for the involved catheter as the lot number could not be provided.All potentially relevant batches have been reviewed.It could not identify any non conformities or deviations relevant to the reported issue.The picco technology is used for advanced hemodynamic monitoring.Based on the information provided by the customer and the investigation results it is considered as unlikely that the device did not meet its specifications.The root cause is seen in a handling error by the user, as the ifu indicates: ¿if resistance is encountered when removing the guide wire, the guide wire could be kinked about tip of catheter within vessel.In this case withdraw the catheter by 2 to 3 cm and try again to remove the guide wire.Use of excessive force may tear off the guide wire.Therefore, guide wire and catheter are to be removed simultaneously.¿.

Event Description

Complaint reference (b)(4).

• Brand Name: PICCO CATHETER
• Type of Device: PROBE, THERMODILUTION
• Manufacturer (Section D): PULSION MEDICAL SYSTEMS SE; hans-riedl-strasse 17; feldkirchen
• MDR Report Key: 8878599
• MDR Text Key: 153815377
• Report Number: 3003263092-2019-00014
• 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: consumer,foreign,user facilit
• Type of Report: Initial,Followup
• Report Date: 09/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PV2015L20-A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2019
• Date Manufacturer Received: 09/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 70