MAUDE Adverse Event Report: SOPHYSA SA PARENCHYMAL PRESSIO CATHETER; ICP PRESSURE MONITORING CATHETER

Model Number ICP CATHETER

Device Problems Difficult to Insert (1316); Connection Problem (2900)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The probe has been returned by distributor on (b)(6) 2017.The analyze has not begun.Internal documentation shows that icp probe has been manufactured in accordance with quality requirements.Further investigation will make it possible to know the causes of the appearance of this incident.

Event Description

The catheter could not plugged into the catheter extension cable.

Manufacturer Narrative

According to sophysa in-house process, the probe (b)(4)/e0160 has been analyzed by the quality control laboratory.The traceability documents do not show any performance abnormality or any causality.Sophysa's manufacturing process includes a icp sensors 100 percent final control.Internal documentation shows that the returned probe correctly satisfied final control requirements.A visual inspection shows that the catheter is cut and an significant part is missing, indeed only the dongle shell and one part of the catheter have been returned.The sight shows that connection pins are not in the axis of the electronics card.Indeed, a deviation of the pins is visible when looking at the dongle shell on the side.This deviation of the connection pins explains the appearance of this event, involving connection difficulties noted by the user.This deviation doesn't make the connection impossible but makes the manipulation a bit difficult.As noted in the product ifu :"do not perform the implantation of a monitoring catheter without having a replacement kit available in case it is required." the assignable cause is an isolated case of inclination of the pins.As a result an incoming inspection of the 100 percent electronic cards has been implemented to guarantee the absence of pins diversion.Finally, the event did not contribute to a serious injury within the meaning of 21 cfr part 820.Indeed, the patient consequences do not necessitates medical intervention to preclude permanent impairment of function and do not result in permanent impairment of a body function.

Event Description

The catheter could not plugged into the catheter extension cable.

• Brand Name: PARENCHYMAL PRESSIO CATHETER
• Type of Device: ICP PRESSURE MONITORING CATHETER
• Manufacturer (Section D): SOPHYSA SA; 5, rue guy moquet; orsay, 91400 ; FR 91400
• Manufacturer Contact: jean-christophe audras ; 5, rue guy moquet; orsay, 91400 ; FR 91400
• MDR Report Key: 6803037
• MDR Text Key: 83135700
• Report Number: 3001587388-2017-17360
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K062584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/18/2017

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: No Information
• Device Expiration Date: 03/01/2022
• Device Model Number: ICP CATHETER
• Device Catalogue Number: PSO-PT
• Device Lot Number: E0160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/25/2017
• Initial Date FDA Received: 08/18/2017
• Supplement Dates Manufacturer Received: 07/25/2017
• Supplement Dates FDA Received: 12/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention