MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS INLIN VLV ONLY W/SPHNGD; CERTAS PLUS W/ SG

Catalog Number 828804

Device Problem Obstruction of Flow (2423)

Patient Problem Injury (2348)

Event Date 02/06/2021

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 physician reported that the certas plus w/sg valve was implanted to the patient via v-p shunt on (b)(6) 2021 with unknown settings.The physician suspected a valve occlusion after the procedure.On (b)(6), a shunt revision for shunt reconstruction was implemented.The physician confirmed the outflow from the abdominal cavity side.Therefore, the physician decided not to replace the valve.On (b)(6) 2021, the patient¿s symptoms worsened, and the product was replaced with another product.The progress was good.No further information was provided from the hospital.

Manufacturer Narrative

The certas valve was returned for evaluation: failure analysis: the position of the cam when valve was received was at setting 1.The valve was visually inspected; the needle guard was raised, as well as needle holes noted in the needle chamber.The valve was hydrated.The valve was leak tested and only leaked from the needle hole in the needle chamber.The valve passed the test for programming, occlusion, reflux, siphon guard and pressure.The needle chamber was dismantled; the needle guard was bent, and glue traces were noted on the needle guard and the silicone housing base.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 problem reported by the customer could have been due to the raised needle guard this is probably due to wrong handling as noted in the "ifu" : do not fold or bend the valve, folding or bending might cause rupture of the silicone housing, needle guard disc dislodgement or occlusion of the fluid pathway, at the time of investigation no occlusion was noted.

Event Description

N/a.

• Brand Name: CERTAS INLIN VLV ONLY W/SPHNGD
• 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: 11389500
• MDR Text Key: 233966909
• Report Number: 3013886523-2021-00093
• 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: 05/05/2021

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: 828804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• Initial Date Manufacturer Received: 02/07/2021
• Initial Date FDA Received: 02/27/2021
• Supplement Dates Manufacturer Received: 04/20/2021
• Supplement Dates FDA Received: 05/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1