MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS PLUS INLINE VALVE ONLY

Catalog Number 828800PL

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/31/2020

Event Type  malfunction  

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 that the certas plus inline valve settings moved after a patient went into the mri scanner.No further information was provided.

Manufacturer Narrative

Unique device identifier (udi)- (b)(4).The certas valve was not returned for evaluation(still implanted), therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.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.The possible root cause for ¿settings moved¿ could be due to the fact that ¿physician thinks they changed the op and they haven't" that may occur for example if "helical spring fails to hold rc in a seated position".As specified in the ifu in warning section : "testing shows that the valve mechanism is resistant to unintended changes in the setting in a 3tesla mri.However, the clinician should confirm the valve setting after a magnetic resonance imaging (mri) procedure.The valve setting is adjusted with the application and manipulation of strong magnets.A change to the valve setting is unlikely to occur under normal circumstances.However, magnetic fields should not be placed near the valve due to the possibility of an unintentional setting change¿.

• Brand Name: CERTAS PLUS INLINE VALVE ONLY
• Type of Device: CERTAS PLUS
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 10550693
• MDR Text Key: 207512461
• Report Number: 3013886523-2020-00111
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 08/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 828800PL
• Device Lot Number: 4031296
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1