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

Model Number NOT PROVIDED

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Further information has been requested and investigation is ongoing.Communication with the physician revealed that the patient suffered vascular diseases and had narrow vessels.According to the physician a 4f or 5f catheter has been used.A supplemental emdr will be sent when the investigation is completed.Device has not been returned by the hospital.

Event Description

Several days after insertion procedure it has been detected that the guidewire was fractured on insertion of device and a small part has migrated up the transducer set.The transducer set has been removed from the patient.No harm or clinical consequences occurred due to the reported event.Manufacturer reference #: (b)(4).

Manufacturer Narrative

No further information like product type or batch number has been provided by the customer despite several requests.Only the small part, which migrated up the transducer set, has been returned and could be confirmed as part of a guidewire.Information provided by the customer revealed that it took several attempts to insert the guidewire.According to the customer, the procedure had to be abandoned at least once as the guidewire could not be inserted properly and resistance was encountered when removing the guidewire.The catheter could be inserted without any particular problems.A x-ray check of the patient did not indicate that parts remained in the patient.The patient died in the meantime, but the death is related to the general sickness of the patient and not to this reported event.Microscopic investigation of the small part revealed kinks and uncoiling as well as a tapered end on the fragmented side.These are indications for the use of excessive force.It is not known what exactly led to the problems during insertion procedure.But it is considered as very likely that patient factors contributed to the situation.The customer confirmed that the patient suffered vascular diseases and had narrow vessels.Contraindications are stated in the ifu.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.Based on the information provided by the customer and the investigation results the root cause is seen in a handling error by the user by using excessive force supported by patient factors.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.¿.It can be concluded that there is no indication for a systematic root cause as a deficiency of design, production or material considering the very low complaint rate ((b)(4), considering all types of picco catheters).The accessory guidewire supplied with the product picco catheter is state of the art.Additionally, the procedure to insert a catheter (¿seldinger technique¿) is state of the art for healthcare professionals and not dependent on the picco technology.A dhr review could not be performed as no batch number has been provided.The issue will be further monitored on the market in order to identify early trends.

Event Description

Manufacturer reference #: (b)(4).

• 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: 10217765
• MDR Text Key: 200769783
• Report Number: 3003263092-2020-00006
• 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
• Type of Report: Initial,Followup
• Report Date: 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NOT PROVIDED
• Device Catalogue Number: NOT PROVIDED
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2020
• Date Manufacturer Received: 07/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1