MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS INLIN VLV SPHN/UNIT CAT; CERTAS PLUS W/ SG

Catalog Number 828806

Device Problem Infusion or Flow Problem (2964)

Patient Problems Swelling (2091); Injury (2348)

Event Date 08/19/2020

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 fluid retention on a patient with a certas valve: the valve was implanted via l-p shunt.On (b)(6) 2020 with unknown setting.The valve was used with the silascon® lumbar catheter (manufactured by kaneka, product code: 702-jj).About one month after surgery, as the patient's abdominal swelling did not subside, an x-ray was performed, and fluid retention was found at the route of the abdominal catheter.Therefore, the valve was replaced with a new one on (b)(6) 2020.

Event Description

N/a.

Manufacturer Narrative

Unique device identification (udi): (b)(4).The valve was returned for evaluation: review of the history device records was not possible as the lot number was unknown.Failure analysis - the valve was visually inspected; it was noted that the silicone was cut/torn around the siphon guard and marks were noted in the siphon guard, as well as needle holes in the needle chamber.The valve passed the test for programming, occlusion, siphon guard and pressure.The valve leaked from the needle holes in the needle chamber and from the tear/cut in the silicone housing around the siphon guard.Root cause analysis - no root cause could be determined for the problem reported by the customer as the technician could not confirm any occlusion with the valve at the time of investigation.The root cause for the cut/tear in the silicone housing around the siphon guard noted during the investigation, was probably caused by a sharp or pointed object coming into contact with the silicone housing, as noted in the ifu silicone has a low cut/tear resistance.The possible root cause for a fluid retention 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 occlusion was noted.

• Brand Name: CERTAS INLIN VLV SPHN/UNIT CAT
• Type of Device: CERTAS PLUS W/ SG
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 10517852
• MDR Text Key: 206501772
• Report Number: 3013886523-2020-00097
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K143111
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 08/24/2020

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: 828806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Initial Date Manufacturer Received: 08/24/2020
• Initial Date FDA Received: 09/10/2020
• Supplement Dates Manufacturer Received: 10/02/2020
• Supplement Dates FDA Received: 10/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 88 YR