FDA Adverse Event Malfunction Summary report: N

VENTRICULAR PRESSIO CATHETER

MDR report key: 7937456 · Received October 5, 2018

Report

Report Number: 3001587388-2018-18436
Event Type: Malfunction
Date Received: October 5, 2018
Date of Event: September 18, 2018
Report Date: September 27, 2018
Manufacturer: SOPHYSA SA
Product Code: GWM
PMA / PMN Number: K162108
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CH
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

INFORMATION ADDED : SERIAL NUMBER, UDI NUMBER, EXPIRATION DATE, MANUFACTURE DATE. ACCORDING TO SOPHYSA IN-HOUSE PROCESS, THE PROBE HAS BEEN ANALYSED BY OUR QUALITY CONTROL LABORATORY AND A VISUAL EXAMINATION AND A FUNCTIONAL CONTROL WERE PERFORMED. A VISUAL EXAMINATION REVEALED DIFFERENT CUTS ON THE TUBING THAT COULD EXPLAINED THE FLUID LEAK OBSERVED. FURTHERMORE, INTERNAL DOCUMENTATION SHOWS THAT THE CATHETER HAS BEEN MANUFACTURED IN ACCORDANCE WITH QUALITY REQUIREMENTS AND WAS RELEASED WITHOUT ANY MANUFACTURING DEFECT ON THE TUBING. THE ASSIGNABLE CAUSE OF THE EVENT COULD BE DUE TO A REMOVAL OF THE STYLET AND RE-POSITIONING BY THE USER IN THE WRONG CHANNEL DURING THE IMPLANTATION OR A USE OF A SHARP OBJECT DURING THE IMPLANTATION.

Description of Event or Problem · 0

A CEREBROSPINAL FLUID LEAKAGE HAS BEEN FOUND AFTER ICP VENTRICULAR CATHETER IMPLANTATION WHEN PRE-INSERTED STYLET HAS BEEN REMOVED.

Additional Manufacturer Narrative · 1

THE EXPERTISE OF THE SUSPECTED MEDICAL DEVICE HAS NOT BEGUN BECAUSE THE DEVICE HAS NOT BEEN RECEIVED YET.

Description of Event or Problem · 1

A CEREBROSPINAL FLUID LEAKAGE HAS BEEN FOUND AFTER ICP VENTRICULAR CATHETER IMPLANTATION WHEN PRE-INSERTED STYLET HAS BEEN REMOVED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
780179	VENTRICULAR PRESSIO CATHETER	ICP PRESSURE MONITORING CATHETER	GWM	SOPHYSA SA	ICP CATHETER	18C32714

Patients

Seq	Age	Sex	Outcome	Treatment
1	56 YR		Required Intervention