MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CRTS SM IL SG VLV ONLY; CERTAS PLUS SMALL & RA W/SG

Catalog Number 828814

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 03/31/2023

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

1 of 2 reports.Other mfg report number: 3013886523-2023-00120 a physician reported a certas valve (id 828814) was implanted in a 49 year-old female patient via ventriculo-peritoneal shunt on (b)(6) 2023 with unknown setting.It was used with bactiseal catheter (id 823072).Since the skin on the head became thin and the valve became visible under the skin, the shunt system was removed and replaced on (b)(6) 2023.According to information provided, it is unknown if the patient experienced any signs and symptoms.

Event Description

N/a.

Manufacturer Narrative

Unique device identifier (udi): (b)(4).The certas valve (id 828814) was returned for evaluation.Failure analysis - the position of the cam when valve was received was at setting 6.The valve was visually inspected; no defects were noted.The valve passed the test for programming, occlusion, leaks, reflux, siphon guard and pressure.Root cause - no root cause could be determined as the technician could not confirm any problem with the valve at the time of investigation.The root cause for the issue reported by the customer, is probably due to incorrect placement of valve implantation.

• Brand Name: CRTS SM IL SG VLV ONLY
• Type of Device: 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: 16765935
• MDR Text Key: 313558145
• Report Number: 3013886523-2023-00119
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K182265
• 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: 07/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 828814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2023
• 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: 49 YR
• Patient Sex: Female