MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CRTS RA SG VLV UTZ CATH ACC; CERTAS PLUS SMALL & RA W/SG

Catalog Number	828826
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Headache (1880); Cerebral Ventriculomegaly (2133)
Date of Event	09/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
A physician reported a certas valve (b)(6) was implanted via ventriculo-peritoneal shunt on (b)(6) 2021 with setting 4.On (b)(6) 2023, the patient presented with a headache, x-ray was performed showing ventricular enlargement.There was no change in the ventricles even when the set pressure was lowered stepwise from 3 to 2 to 1.Since obstruction was suspected, the valve was removed and replaced on (b)(6) 2023.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Certas valve (id 828826) was returned for evaluation.Failure analysis - the position of the cam when valve was received was at setting 1.The valve was visually inspected, a needle hole in the needle chamber was noted.The valve was hydrated.The valve passed the test for programming, occlusion, reflux, siphon guard and pressure.The valve was leak tested and only leaked from the needle hole in the needle chamber.The catheters were irrigated, no occlusions noted.Root cause analysis- no root cause could be determined for the issue reported by the customer as the technician could not confirm any problem with the valve at the time of investigation.A 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 no occlusion issues with the valve were noted.

• Brand Name: CRTS RA SG VLV UTZ CATH ACC
• Common Device Name: CERTAS PLUS SMALL & RA 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: 17961980
• Report Number: 3013886523-2023-00363
• Device Sequence Number: 6565218
• Product Code: JXG
• UDI-Device Identifier: 10886704082033
• UDI-Public: 10886704082033
• Combination Product (Y/N): N
• PMA/510(K) Number: K182265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 828826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 11/10/2023
• Initial Report FDA Received Date: 10/18/2023
• Supplement Report FDA Received Date: 11/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Sex: Female