MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS PLUS INLINE WITH SIPHON; CERTAS PLUS W/ SG

Model Number 828804PL

Device Problem Disconnection (1171)

Patient Problems Headache (1880); Vomiting (2144); Ambulation Difficulties (2544)

Event Date 10/18/2022

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.(b)(4).

Event Description

A facility reported a certas valve (id 828804pl) was implanted on (b)(6) 2022.The patient started with signs of shunt dysfunction (difficulty in maintaining balance, vomiting, loss of consciousness and headache).When the skin was opened and subcutaneous tissue was dissected the valve was exposed and seen with a disconnection between the valve program and the antisiphon device, presenting leakage of cerebrospinal fluid from this area.The ventricular and atrial catheter were checked and found in a good condition and function.Timeframe between the implantation and the onset of signs and symptoms was 5 months.The valve was removed and replaced on (b)(6) 2022.The patient is at home without any symptoms.

Manufacturer Narrative

Updated fields:  d4, d9, g3, g6, h2, h3, h4, h6, h10.The certas valve (id 828804pl) was returned for evaluation.Device history record (dhr) - the product code 82-8804pl with lot 6247720, conformed to the specifications when released to stock.Failure analysis - the position of the cam when valve was received was at setting 2.The valve was visually inspected; a cut/tear in the silicone housing around the siphon guard and cuts in the silicone housing over the valve casing were noted and a needle hole was noted in needle chamber.The valve was hydrated.The valve was leak tested and only leaked from the needle hole in the needle chamber and the cut/tear in the silicone housing around the siphon guard.The valve could not be reflux due to the damaged silicone housing.The siphon guard was visually inspected; marks were noted in the siphon guard.The valve passed the test for programming, occlusion, siphon guard and pressure.The root cause for the ¿partial rupture of the shunt in the area where the anti-siphon¿ reported by the customer, is probable due to 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 are probably due to a sharp or pointed object coming into contact with the siphon guard.The root cause for the ¿fluid accumulation was observed in the area surrounding the shunt¿ issue reported by the customer is probably due to the cut/tear in the silicone housing causing csf liquid to leak out into unintentional parts of the body.

Event Description

N/a.

• Brand Name: CERTAS PLUS INLINE WITH SIPHON
• Type of Device: CERTAS PLUS W/ SG
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• Manufacturer (Section G): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; ch-2400; le locle ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 15716275
• MDR Text Key: 302874918
• Report Number: 3013886523-2022-00501
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 828804PL
• Device Catalogue Number: 828804PL
• Device Lot Number: 6247720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female