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

Model Number PV2014L16-A

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/03/2020

Event Type  malfunction  

Manufacturer Narrative

Further information has been requested, and investigation is ongoing.Follow up with the hospital regarding the death is ongoing, and the report will be updated accordingly if contradicting information is received.A supplemental emdr will be sent when the investigation is completed.

Event Description

Picco catheter 4f 16cms snapped on removal from patients rt femoral artery.7.5cms of line retained in the patient.An ultrasound scan (uss) of groin has been carried out after picco catheter removal; monitoring and review by vascular surgeon.There was no thrombus, no evidence of false aneurysm of bleeding, the end line fractured and a few centimeters retained.The retained part has not been removed from the patient.Patient suffered a cardiac arrest on (b)(6) 2020, and subsequently died.According to the hospital a relation between the death and the event is not clarified.Provided information of circumstances, and patient´s sickness do not indicate a relation according to internal medical assessment.Manufacturer reference #: (b)(4).

Event Description

Manufacturer reference #: 389685.

Manufacturer Narrative

The part of the picco catheter, which has been removed from the patient, has been investigated with a microscope.The second part has been retained in the patient.The picco catheter tubing snapped at approximately 8,5cm.The surfaces of fracture showed an area with a sharp edge, clear and sharp surface.As well as an area with a wavelike, irregular surface.A dhr check could not identify any non-conformities or deviations relevant to the reported issue.No cases about a completely snapped catheter tubing has been reported within at least 24 months.Considering the investigation results, the overall circumstances and the trending, a design or production related root cause is seen as unlikely.The most probable root cause for the fracture of the picco catheter tubing is seen in an user error by accidentally cutting the tubing (indicated by the sharp edge, clear and sharp surface).And additionally applying excessive force during removal (wavelike, irregular surface).The ifu indicates: "warning: do not alter or cut the catheter, guide wire, or any other set component during insertion, use or removal." in general, the catheter tubing shall withstand a high tensile force of > 20 n, which is tested during incoming inspection.Information provided by the hospital revealed that problems have been encountered during removal.A significant resistance has been noted.Multiple attempts have been needed to remove the catheter.This supports the evaluation that the catheter was structurally whole and withstood the applied force multiple times before it fractured, likely supported by the cut.No issues have been encountered during measurement.A major defect would have likely been detected during measurement.It is not known what caused the resistance.It is not normal to encounter resistance when removing an arterial line.No ultrasound has been performed during removal.The ultrasound performed after removal showed no indication of abnormalities.It cannot be excluded that patient factors contributed to the event.Overall, investigations did no indicate that the device failed to meet its specification when the event occurred.Upon the event occurrence the device was involved and used on a patient for advanced hemodynamic monitoring.The procedure to insert or remove a catheter is state of the art for the healthcare professionals and not dependent on the picco technology.No further information related to the circumstances of the death has been received.The internal review performed by the medical department concluded the following: a causal relationship between a catheter embolization and patient death is deemed to be very unlikely.The patient in question suffered from severe cardiac disease with multiple comorbidities and had a poor overall prognosis.Due to the patient¿s history of myocardial infarction, severely deteriorated global cardiac function and prior intrahospital cardiac arrest, it seems highly likely that the death of the patient was a result of severe disease and deteriorating health and not from a catheter embolization.The issue will be further monitored on the market to identify early trends.

• Brand Name: PICCO CATHETER
• Type of Device: PROBE, THERMODILUTION
• Manufacturer (Section D): PULSION MEDICAL SYSTEMS SE; hans-riedl-strasse 17; feldkirchen 85622 ; GM 85622
• MDR Report Key: 10866822
• MDR Text Key: 217710535
• Report Number: 3003263092-2020-00015
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PV2014L16-A
• Device Catalogue Number: 6886146
• Device Lot Number: 676063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Date Manufacturer Received: 12/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 66