MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR LONG HAKIM VENTRICULAR CATHETE; STANDARD CATHETERS

Catalog Number NS9001

Device Problem Obstruction of Flow (2423)

Patient Problems Fever (1858); Headache (1880)

Event Date 08/12/2021

Event Type  Injury  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

3 of 3 reports.Other mfg report numbers: 3013886523-2021-00379.3013886523-2021-00380.A physician reported a suspected shunt obstruction and infection of a codman certas plus programmable in-line valve.The valve was implanted in a (b)(6) male patient with a cerebral stroke via ventricular peritoneal shunt on (b)(6) 2021 with an initial setting of 3.The valve was used with 823045 (serial; unk) and ns9001long hakim ventricular catheter (serial; unk).On (b)(6) 2021 the patient presented with a headache.The valve reservoir was pumped due to suspicion of obstruction, but the reservoir did not return immediately.On (b)(6) 2021 the patient had a fever.As a result of draining the cerebrospinal fluid from the reservoir and examining it, infection was found.The type of infection/organism and what laboratory tests were done to confirm the infection were unknown.It is unknown if the patient was administered medications for the suspected infection.The patient was taken to surgery on (b)(6) 2021 and the shunt system was removed.The patient is scheduled to go back to the operating room on once their condition is stable to re-implant a certas valve.The patient is in follow up.No further information was provided by hospital.

Manufacturer Narrative

The ventricular catheter was not returned for evaluation (as per customer, product not available) and no lot number information has been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: LONG HAKIM VENTRICULAR CATHETE
• Type of Device: STANDARD CATHETERS
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 12409089
• MDR Text Key: 280547862
• Report Number: 3013886523-2021-00381
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: NI
• 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: 10/06/2021

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: NS9001
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/16/2021
• Initial Date FDA Received: 09/01/2021
• Supplement Dates Manufacturer Received: 09/23/2021
• Supplement Dates FDA Received: 10/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR