MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR PROG VALVE INLINE W SG; CHPV WITH SG

Catalog Number 823832

Device Problem Break (1069)

Patient Problems Bacterial Infection (1735); Fever (1858); Neck Stiffness (2434)

Event Date 02/01/2021

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

A facility reported a shunt infection post implantation.The patient was implanted with a hakim programmable valve on (b)(6) 2021 after injuries sustained from a severe car accident.It was reported after the procedure the silicone valve was broken out and the patient developed an infection.The signs and symptoms of the infection included high fevers and nuchal rigidity, and a cerebral spinal fluid cell count of cell count 1000+.The patient was treated with antibiotics and the product was explanted on (b)(6) 2021 and replaced with the valve of another company.In regard to the patients current status, it was reported the ¿infection is getting worse and the relatives gave up the treatment.¿.

Event Description

N/a.

Manufacturer Narrative

Updated fields:  d4, d9, g3, g6, h2, h3, h4, h6, h10.The hakim valve was returned for evaluation.Device history record (dhr) - review of the history device records for the product code 823832 with lot 4218862 conformed to the specifications when released to stock failure analysis - the valve was visually inspected, a tear/cut was noted in the silicone housing from the end of the valve casing to the end of the siphon guard.The position of the cam when valve was received was 140mmh2o.The valve was then pressure tested according to test method the valve failed the test, due to the tear/cut in the silicone housing.The siphon guard was visually inspected, and cut/scratch marks were noted on the siphon guard.The root cause for the tear/cut in the silicone housing reported by the customer is probably due to a sharp or pointed object coming into contact with the silicone housing, as noted in the ifu silicone has a low tear/cut resistance.The cut/scratch marks in the siphon guard are due to a sharp or pointed object coming into contact with the siphon guard.The possible root cause for the infection issue, could be linked to the patient and hospital surroundings.As no discrepancies were found with the sterilization certificate.

• Brand Name: PROG VALVE INLINE W SG
• Type of Device: CHPV WITH SG
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 11578492
• MDR Text Key: 242675807
• Report Number: 3013886523-2021-00139
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K053107
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 823832
• Device Lot Number: 4218862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• Date Manufacturer Received: 04/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1