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

Model Number PV2014L16N

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/25/2020

Event Type  malfunction  

Manufacturer Narrative

Further information has been requested and investigation is ongoing.A supplemental emdr will be sent when the investigation is completed.Product not returned.

Event Description

Prior to puncture, the picco catheter was inspected.It was detected that the picco catheter connection to the pressure transducer connector end is leaking (less than 5 ml).The product has been replaced immediately.No harm or clinical consequences occurred.Manufacturer reference #: (b)(4).

Manufacturer Narrative

The complained catheter has been returned for investigation.No indications for a material deficiency (like air bubbles, particles) could be detected by naked eye and under the microscope.A simulated leakage test of the complained device could confirm the leakage as described in the complaint.A dhr review could not identify any non-confomities or deviations relevant to the reported issue.A 100 % leakage test is performed during production.A systematic weakness in the production process is considered as unlikely due to the very low complaint rate (<0,01 % for all types of picco catheter).No similar complaints have been received for this batch.Considering the complaint investigation results and the appearance of the crack (linear shaped propagation, originating from luer lock connection) it is seen most probably that excessive force (potentially by overriding the connection between pressure transducer and catheter) in combination with alcoholic disinfectant has been applied.According to the customer no alcoholic disinfectant has been used.It cannot be exluded that any unknown tool has been used to tighten the connection.Upon the event occurrence the device was involved, but not used on a patient.The issue has been detected prior to puncture, when the catheter was inspected and connected to the pressure transducer.The evaluation results did not indicate that the device failed to meet its specification.The ifu states: ¿the luer-lock connection is to be tightened manually.The use of any tools or excessive force may damage the connection component and lead to leakiness.¿ and "usage of organic solvents for cleaning and disinfection may damage the catheter and lead to leakiness.¿ the issue will be further monitored on the market in order to indentify any trend.

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: 10312549
• MDR Text Key: 200049651
• Report Number: 3003263092-2020-00009
• Device Sequence Number: 1
• Product Code: KRB
• UDI-Device Identifier: 04250094500658
• UDI-Public: (01)04250094500658(17)220228(11)170314(10)619483
• 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
• Type of Report: Initial,Followup
• Report Date: 08/13/2020

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 Expiration Date: 02/28/2022
• Device Model Number: PV2014L16N
• Device Catalogue Number: 6885052
• Device Lot Number: 619483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2020
• Initial Date Manufacturer Received: 07/13/2020
• Initial Date FDA Received: 07/23/2020
• Supplement Dates Manufacturer Received: 08/13/2020
• Supplement Dates FDA Received: 08/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 58