MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS INLINE W/SPHNGD/BAC CAT; CERTAS PLUS W/ BACTISEAL & SG

Catalog Number 828807

Device Problems Mechanical Problem (1384); Infusion or Flow Problem (2964)

Patient Problem Insufficient Information (4580)

Event Date 02/13/2024

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.

Event Description

A facility reported a certas valve was implanted via v-p shunt on (b)(6) 2024 with unknown setting.After implanting the valve, the surgeon could not confirm its csf flow, therefore, the valve was explanted during the procedure.It was confirmed that the needle guards came off and blocking the flow path.The procedure was completed with a replacement product available and the event led to more than 30 minutes surgical delay.

Manufacturer Narrative

The certas valve (id 828807) was returned for evaluation.Device history record (dhr) ¿ the product code 828807 with lot 7293137, conformed to the specifications when released to stock.Failure analysis - the position of the cam when valve was received was at setting 4.The valve was visually inspected; the needle guard was raised.The valve passed the tests for occlusion.The catheters were irrigated no occlusions noted.The needle chamber was dismantled; the needle guard was bent, and glue traces were noted on the needle guard and the silicone base.Root cause analysis - no occlusion issues were noted.A root cause for the bent needle guard issue reported by the customer is due to wrong handling as noted in the instruction for use (ifu): do not fold or bend the valve, folding or bending might cause rupture of the silicone housing, needle guard disc dislodgement or occlusion of the fluid pathway.A possible root cause for the issue ¿the surgeon could not confirm its csf flow.¿ reported by the customer could have been due to the raised needle guard.As shown in the investigation no occlusion issues were noted, it is possible that the needle guard has moved and freed the flow passage.

• Brand Name: CERTAS INLINE W/SPHNGD/BAC CAT
• Type of Device: CERTAS PLUS W/ BACTISEAL & 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: 18788937
• MDR Text Key: 336396036
• Report Number: 3013886523-2024-00054
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 10381780515876
• UDI-Public: (01)10381780515876(17)240831(10)7293137
• 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,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/19/2024

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 828807
• Device Lot Number: 7293137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2024
• Initial Date FDA Received: 02/27/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2023
• 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