MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR PROG VALVE INLINE W SG; CHPV WITH SG

Catalog Number	823162
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Vomiting (2144)
Date of Event	07/27/2024
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
This is 1 of 2 reports linked to mfg report number: 3013886523-2024-00259.A physician reported a hakim valve (id 823162) was implanted due to normal pressure hydrocephalus (nph) via ventriculoperitoneal (vp) shunt on unknown date with unknown setting.The valve was used along with the ventricular catheter (id 823073) and peritoneal catheter (id 823074).The patient is a 3.5 year-old male, and the valve and catheters were implanted when the patient was 5 months old.On (b)(6) 2024, the consciousness level of the patient had declined and was vomiting.A slit-like ventricle was observed on x-ray, and ct scan showed that the ventricular catheter (id 823073) had fallen off.A revision surgery was performed, the valve and the ventricular catheter were explanted and replaced with a new device on (b)(6) 2024 except for the peritoneal catheter.There is no issue with the peritoneal catheter.The patient recovered.
Additional Manufacturer Narrative
Updated fields: d9, g3, g6, h2, h3, h4, h6, h11.The hakim valve (id 823162) was not returned for evaluation after three good faith attempts (gfes) were made.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause of the reported issue could not be determined.However, the possible root cause for the issue reported by the customer could be due to not securing the catheter when implanted.However, it was not possible to confirm and identify the root cause of this assumption as the product was not returned for investigation.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The hakim valve (id 823162) was returned for evaluation.Device history record (dhr) - the product code 82-3162 with lot 4175406, conformed to the specifications when released to stock.Failure analysis - the position of the cam when valve was received was on setting 80 mmh2o.The valve was visually inspected; connector was missing, and catheter not received.A cut mark was noted on the housing.The valve was tested for programming; the valve failed the test.The valve passed the test for occlusion, leak, reflux, and siphon guard.The pressure test could not be performed as the device could not be programmed.The valve was visually inspected under microscope at appropriate magnification; biological debris was found on the ruby ball, motor and on the seat of the ruby ball.Root cause analysis - the possible root cause for the ventricular connector and missing proximal connector could be due to atypical handling during the implantation.However, it was not possible to confirm and identify the root cause of this assumption as the catheter was not returned for investigation.The possible root cause for the programming issue is due to biological debris and protein build up interfering with the valve.The root cause for the ¿cut marks¿ is due to a sharp or pointed object coming into contact with the valve or atypical handling, as noted in the surgical procedure precautions section in instruction for use (ifu), silicone has a low cut/tear resistance.
Event or Problem Description
N/a.

• Brand Name: PROG VALVE INLINE W SG
• Common Device Name: CHPV WITH 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 08540 ; 6099362319
• MDR Report Key: 20081743
• Report Number: 3013886523-2024-00258
• Device Sequence Number: 7810974
• Product Code: JXG
• UDI-Device Identifier: 10381780534570
• UDI-Public: (01)10381780534570(17)280430(10)4175406
• Combination Product (Y/N): N
• PMA/510(K) Number: K221840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2024
• Device Catalogue Number: 823162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2024
• Supplement Date Received by Manufacturer: 10/11/2024; 12/09/2024
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 10/31/2024; 12/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PERITONEAL CATHETER (ID 823074.; VENTRICULAR CATHETER (ID 823073.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 3 YR
• Patient Sex: Male