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

Catalog Number 828806

Device Problem Output Problem (3005)

Patient Problem Hematoma (1884)

Event Date 08/10/2021

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 that the certas plus valve was implanted to a (b)(6)-year-old male patient via l-p shunt on (b)(6) 2021, with a setting of 5.The valve was used with the silascon® lumbar catheter (manufactured by kaneka, product code: 702-jj).The setting was placed at 5, but then a hematoma appeared due to excessive flow.The setting was immediately changed to 8.The physician then tried changing the setting from 8 to 7, but the set pressure was unable to be changed.A setting of 4 was confirmed with the toolkit and etk.However, a setting of 8 was displayed and confirmed by x-ray.Valve reversal was suspected, and an unknown additional action was planned for august 12 (no information provided).The patient is currently in follow up.No further information was provided by hospital.

Event Description

N/a.

Manufacturer Narrative

The certas valve was not returned for evaluation (as per customer, product not available) and no lot number information has been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.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 the reported ¿valve reversal suspected" could be due to "valve is not sufficiently fixated when placed in the lumbar space (suture tabs not sufficiently utilized)".

• 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: 12402945
• MDR Text Key: 269332915
• Report Number: 3013886523-2021-00377
• 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,health professional
• Type of Report: Initial,Followup
• Report Date: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• 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?: No
• Date Manufacturer Received: 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SILASCON LUMBAR CATH(MANUF KANEKA, PROD: 702-JJ).; SILASCON LUMBAR CATH(MANUF KANEKA, PROD: 702-JJ).
• Patient Age: 91 YR