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

Catalog Number 828806

Device Problem Infusion or Flow Problem (2964)

Patient Problem Hematoma (1884)

Event Date 08/06/2021

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 a distal drainage issue of a certas plus programmable in-line valve.The valve was implanted in a patient with a craniopharyngioma via a ventricular peritoneal shunt in 2019 with an unknown initial setting.A subdural hematoma was observed, the physician decided to see how it will go with a setting of 6.The patient's motor function reportedly got better for a while, but after that, the situation got worse.Ventricular enlargement was observed, and cerebral spinal fluid was removed from the reservoir a few times.Protein concentration was checked, and it was indicated 340mg/dl at the first time and was 540 mg/dl at the 2nd time.When the contrast agent was performed, it was found that flow was confirmed from the ventricular side, but not confirmed from the peritoneal side.The patient was taken to the operating room on (b)(6) 2021 and the valve and the ventricular catheter were removed.And the peritoneal catheter was cut at its halfway point and the remaining catheter was left in place.A new fixed pressure valve was manually connected with the peritoneal catheter with using a connector.After revision, agent contrast was flowed without problem.The patient is in follow-up.No further information was provided by hospital.

Event Description

N/a.

Manufacturer Narrative

The certas valve was returned for evaluation.Failure analysis - the position of the cam when valve was received was at setting 6.The valve was visually inspected; it was noted that the silicone was cut/torn around the siphon guard as well needle holes in the needle chamber were noted.The valve was hydrated.The valve was leak tested only leaked from the needle holes in the needle chamber no leakage was noted from the cut/tear in the silicone housing over the siphon guard.The catheters were irrigated, no occlusions noted.The valve passed the test for programming, occlusion, reflux and siphon guard.No root cause could be determined as the technician could not confirm any functional issues with the valve at the time of investigation.The possible root cause for the issue reported by the customer could be due to biological debris and protein build up interfering with the valve mechanism, at the time of investigation the no functional issues were noted with the valve.The root cause for the cut/tear found in the silicone housing around the siphon guard was due to a sharp or pointed object coming into contact with the catheter, as noted in the ifu, silicone has a low tear/cut resistance, no leakage was noted from the cut/tear at the time of investigation.

• 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
• 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: 12403035
• MDR Text Key: 269326421
• Report Number: 3013886523-2021-00378
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/11/2021

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 79 YR
• Patient Sex: Male