MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CRTS SM IL SG VLV ONLY; CERTAS PLUS SMALL & RA W/SG

Catalog Number 828814

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Failure of Implant (1924); Injury (2348)

Event Date 10/05/2020

Event Type  Injury  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A physician reported the certas valve was implanted via v-p shunt on (b)(6) 2020 with a setting of 6.On (b)(6) 2020, a subdural hematoma was observed so the valve was set to a setting of 8, virtual-off.On (b)(6) 2020, the setting was changed to 7, and the setting continued to be gradually changed to a setting of 1 by (b)(6).Since (b)(6) 2020, csf retention under skin was observed around puncturing position of ventricular catheter.An mri showed that the ventricular catheter immigrated to the distal side and was almost out of the ventricle.On (b)(6) 2020, the valve was replaced to a new one (chpv).After the valve was removed it was noted that the saline did not come out of the valve.Flow patency was confirmed from the other catheter.

Event Description

N/a.

Manufacturer Narrative

Unique device identifier (udi) : (b)(4).The certas valve was returned for evaluation: failure analysis - the valve was visually inspected, no defects noted.The position of the cam when valve was received was at setting 1.The valve was hydrated.The valve passed the test for programming, occlusion, leak, reflux, siphon guard, and pressure.No root cause could be determined as the technician could not confirm any problem with the valve at the time of investigation.The possible root cause for the issue reported by the customer could be due to biological debris and protein build up this could interfere with the valve mechanism, but at the time of investigation no flow issues were noted.

• Brand Name: CRTS SM IL SG VLV ONLY
• Type of Device: CERTAS PLUS SMALL & RA W/SG
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 10775941
• MDR Text Key: 214532716
• Report Number: 3013886523-2020-00174
• 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
• Type of Report: Initial,Followup
• Report Date: 10/06/2020

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 828814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2020
• Initial Date Manufacturer Received: 10/06/2020
• Initial Date FDA Received: 11/02/2020
• Supplement Dates Manufacturer Received: 11/03/2020
• Supplement Dates FDA Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1