MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD PROGRAMMABLE VALVE INLINE UNTZ; CHPV

Catalog Number	823844
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/14/2023
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 hakim valve (id 823844) was implanted due to subarachnoid hemorrhage via ventriculoperitoneal shunt on (b)(6) 2013 with unknown setting.However, since 2017, the ventricles have not shrunk.The patient symptoms did not change, and was followed up.An obstruction was suspected and the reservoir was pumped, but no abnormality was found in the reservoir.In (b)(6) 2023, a computed tomography scan revealed that the peritoneal catheter had prolapsed, therefore, the valve was removed on (b)(6) 2023 because the patient was also suffering from abdominal disease.The valve was not replaced.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h10.The hakim valve (id 823844) was returned for evaluation.Device history record (dhr) - product code 82-3844 with lot ctmbr3, conformed to the specifications when released to stock.Failure analysis - the valve was visually inspected; no defects noted.The position of the cam when valve was received was 30mmh2o.The valve was hydrated.The valve passed the test for programming, occlusion, reflux and pressure.The valve was leak tested; no leaks were noted.The catheter was irrigated; no occlusions noted.The valve was dried.The catheter was visually inspected; one end shows signs of being attached to a connector no damage was noted with the piece of catheter returned.Root cause analysis - no root cause could be determined as the technician could not confirm any problem with the valve at the time of investigation.However, a possible root cause for the issue reported by the customer, could be due to a sharp or pointed object coming into contact with the catheter, as noted in the ifu (instructions for use) silicone has a low cut/tear resistance.A possible root cause for the issue ¿an obstruction was suspected¿ reported by the customer, could be due to biological debris and protein build up interfering with the valve mechanism.
Event or Problem Description
N/a.

• Brand Name: PROGRAMMABLE VALVE INLINE UNTZ
• Common Device Name: CHPV
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 17869026
• Report Number: 3013886523-2023-00344
• Device Sequence Number: 18042670
• Product Code: JXG
• UDI-Device Identifier: 10886704041481
• UDI-Public: (01)10886704041481(17)240831(10)CTMBR3
• Combination Product (Y/N): N
• PMA/510(K) Number: K053107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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): 12/01/2023

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 Expiration Date: 08/31/2024
• Device Catalogue Number: 823844
• 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: 09/20/2023
• Supplement Date Received by Manufacturer: 11/24/2023
• Initial Report FDA Received Date: 10/04/2023
• Supplement Report FDA Received Date: 12/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2019
• 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
• Patient Age: 75 YR
• Patient Sex: Female