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

Model Number PVPK2015L20-A

Device Problems Material Frayed (1262); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/21/2024

Event Type  malfunction  

Event Description

It has been reported that during picco catheter installation the guidewire frayed.The physician was able to recover the guidewire and a new picco device was used.No harm to the patient was reported.Manufacturer referance (b)(4).

Manufacturer Narrative

H3 other text : device requested but pending answer.

Event Description

Manufacturer reference #: (b)(4).

Manufacturer Narrative

It has been reported that the guidewire uncoiled during insertion of the picco catheter.The physician managed to recover the guidewire and replaced it with a new picco catheter.Device was available for investigation.The described problem has been evaluated in regards to the following factors: design related factors production related factors user related factors patient related factors design related factors: a design related root cause is considered as unlikely due to the absence of a trend.The complaint rate for all types of picco catheters is very low < 0,01 % considering more than (b)(4) sold catheters per year (all models of picco catheter).The issue has been intensively investigated in the past by the r&d department with the following conclusion: "additionally, design changes of the guidewire (like stainless steel instead of nitinol and welding of tip instead of gluing) have been discussed to decrease the risk of breaking, uncoiling and kinking.But overall, no reasonable design change of the guidewire could be identified.All discussed changes would introduce new risks or increase existing risk, which would not be outweighed by the benefits.Additional potential design changes have been evaluated in regards to the product incl.Labeling from a technical and medical perspective.The results clearly show that the guidewire supplied with the product picco catheter is state of the art.There is no indication that the product picco catheter (incl.Accessories and labeling) is not performant and effective." during r&d testing a similar error pattern could be reproduced when handling against the ifu.Production related factors: the catheter was visually inspected by naked eye.The described problem could be confirmed.The guidewire is uncoiled and elongated at the tip (j-tip) of the guidewire.The soul of the guidewire tip is not separated, and only the outer layer of the guidewire is uncoiled.It seems that the outer layer was elongated from the tip, indicating a use of excessive force.A dhr review did not reveal any non conformity or deviation from specification which could have contributed to the event.Additionally, the ifu indicates to only use products if no sign of damage is visible: "do not use the catheter or accessories if any sign of product damage is visible." the malfunction has been detected when the needle has been withdrawn and not before insertion.There is no indication for a systematic root cause as a deficiency of design, production, material or other considering the very low complaint rate (< 0,01 %, considering all types of picco catheters).Overall, a root cause related to the production process is therefore considered as unlikely.User related factors: unfortunately, a detailed description of the handling when the event occurred was not given.The ifu states clear : 1.¿warning: do not withdraw guide wire against needle bevel to avoid possible severing or damage of guide wire.¿ 2.¿warning: make sure that the introducer cannula is introduced in a flat angle (less than 45°)¿.3."warning: do not alter or cut the catheter, guide wire, or any other set component during insertion, use or removal." 4."warning: do not withdraw guide wire against needle bevel to avoid possible severing or damage of guide wire." 5."warning: the use of any tools or excessive force may damage the connection component and lead to leakiness." 6."warning: kinks, bending or handling with a clamp can irreversibly damage the catheter." patient related factors: patient factors such as vascular anomalies or pathological vascular processes may present difficulties in gaining vascular access such as problems with advancing or removing the guidewire.No patient condition information has been provided by the hospital.The ifu states contraindications : "picco catheters are not intended for any use other than which is indicated.The catheter may not be used in patients where the placement of an indwelling arterial catheter is contraindicated e.G.In the case of arterial prostheses, insufficient perfusion or tissue damages around the puncture site as well as severe peripheral vascular diseases.A picco catheter should only be used if the expected results are reasonable in comparison to the risks." the investigation has been performed to the most possible extent.The exact root cause could not be clarified.Based on the provided information and investigations the most probable root cause for the guidewire deformation is seen in a handling error or procedural issue during guidewire insertion.One potential scenario is that the needle has been introduced not in a flat angle or partly withdrew the guidewire against the needle bevel and the guidewire got stuck on the needle bevel.This could have caused the deformation of the guidewire.The ifu indicates: "warning: do not withdraw guide wire against needle bevel to avoid possible severing or damage of guide wire.¿ and "caution: make sure that the introducer cannula is introduced in a flat angle (less than 45°)." based on the information above, the complaint will be closed.

• Brand Name: PICCO CATHETER
• Type of Device: PROBE, THERMODILUTION
• Manufacturer (Section D): PULSION MEDICAL SYSTEMS SE; hans-riedl-strasse 17; feldkirchen 85622 ; GM 85622
• Manufacturer (Section G): PULSION MEDICAL SYSTEMS SE; hans-riedl-strasse 17; feldkirchen 85622 ; GM 85622
• Manufacturer Contact: diana kitschke ; hans-riedl-strasse 17; feldkirchen 85622 ; GM 85622 ; 0894599140
• MDR Report Key: 18910770
• MDR Text Key: 337740622
• Report Number: 3003263092-2024-00006
• Device Sequence Number: 1
• Product Code: KRB
• UDI-Device Identifier: 04250094500938
• UDI-Public: (01)04250094500938
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K171620
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PVPK2015L20-A
• Device Catalogue Number: 6885049
• Device Lot Number: 726828
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2024
• Initial Date FDA Received: 03/15/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1