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

Catalog Number 828804

Device Problem Material Split, Cut or Torn (4008)

Patient Problems Cerebrospinal Fluid Leakage (1772); Injury (2348)

Event Date 10/22/2020

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

This is 1 of 2 reports.Other mfg report number 3013886523-2020-00193.A facility reported the codman certas valve with sg (model 828804 )and a plain silicon catheter (model refs 823041 and 821684) were implanted to a (b)(6) year old male patient on october 19.Three days post op, the surgeon noticed csf leaking from the incision site.On october 22, the surgeon took the patient back to the or and the certas plus valve and peritoneal catheter were revised (catheter model ref 821684 holter distal peritoneal catheter).It was noted that the valve had split down the middle and the peritoneal catheter had dislodged at the valve connection point.The siphon guard had completely dislodged from the valve.The patient did not experience a fall or hit to the head post op and the surgeon stated that they did not bend the valve on insertion.The ventricular catheter was not revised (model ref 823041 hakim ventricular catheter).

Manufacturer Narrative

Unique device identifier (udi) : (b)(4).The valve was not returned for evaluation 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.

Event Description

N/a.

Manufacturer Narrative

Unique device identifier (udi): (b)(4).The valve was returned for evaluation: device history record (dhr): conformed to the specifications when released to stock failure analysis - the position of the cam when valve was received was at setting 3.The valve was visually inspected; the silicone housing was cut/torn around the siphon guard the complaint is confirmed.The siphon guard was visually inspected marks were noted in the siphon guard.The root cause for the issue reported by the customer the valve has split down the middle, this 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 root cause for the marks in the siphon guard were probably caused by a sharp or pointed object coming into contact with the siphon guard.

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: 10841094
• MDR Text Key: 216332572
• Report Number: 3013886523-2020-00192
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 828804
• Device Lot Number: 4706532
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Date Manufacturer Received: 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR