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

Catalog Number	823162
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Dizziness (2194)
Date of Event	08/12/2024
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
A facility reported a hakim valve (id 823162) and a bactiseal catheter kit (id 823072) were implanted on (b)(6) 2024.On (b)(6) 2024, the patient felt dizzy and in (b)(6) 2024, the pressure of the valve was adjusted to 90mmh2o.On (b)(6) 2024, the physician conducted a revision procedure and found that the valve was broken.Then the valve was removed and replaced.After the procedure, the patient felt better.No additional information was provided after several attempts, therefore, it is unknown if the bactiseal catheter failed, and if the catheter was also removed/replaced.
Additional Manufacturer Narrative
Additional information received: were all the broken parts recovered? "yes." was there any failure observed on the codman bactiseal catheter kit (id 823072)? if yes, a.Please specify the failure: "no failure." b.Was the catheter removed and replaced? "no.".
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 6331803, conformed to the specifications when released to stock.Failure analysis - the position of the cam when valve was received was on setting 70 mmh2o.The valve was visually inspected; the siphon guard was broken.Cut and tear mark were noted on the siphon guard and housing.The complaint was confirmed.Root cause analysis - the root cause for the ¿siphon broken¿ could be 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 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 MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA 02048
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 20472910
• Report Number: 3013886523-2024-00322
• Device Sequence Number: 17955671
• Product Code: JXG
• UDI-Device Identifier: 10381780519232
• UDI-Public: (01)10381780519232(17)270331(10)6331803
• Combination Product (Y/N): N
• PMA/510(K) Number: K221840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/09/2025

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 Catalogue Number: 823162
• Device Lot Number: 6331803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2024
• Supplement Date Received by Manufacturer: 10/22/2024; 12/19/2024
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 11/15/2024; 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2022
• 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: BACTISEAL CATHETER KIT (ID: 823072).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 38 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian