MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CHPV RT ANG RESERVOIR UNITIZED

Catalog Number	823148
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported a patient of unspecified age and gender who had shunt malfunction during the use of chpv shunt (codman hakim programmable valve id 823148) and siphonguard csf control device for an unknown indication.The action taken with chpv shunt (codman hakim programmable valve) and siphonguard csf control device was unknown.Remarks: this case was assessed as serious as other medically important condition.This case was verified by physician.This is a serious case regarding a patient of unspecified age and gender who had shunt malfunction during the use of chpv shunt (codman hakim programmable valve) and siphonguard csf control device for an unknown indication.The causality for the event is considered as not assessable based on nature of the event.However, there is limited information regarding patient demographics, therapy details of the suspect drug, onset date and outcome of the reported event, concomitant medication, relevant medical history and lab data.As per the company manual of both the suspect drugs, the reported event shunt malfunction is labeled.No additional information has been received after several attempts; therefore, patient outcome and event details remains unknown.
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.
Additional Manufacturer Narrative
The hakim valve (id 823148) was not returned for evaluation after three good faith attempts (gfes) were made.Lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.The root cause(s) of the reported issue could not be determined.However, a probable root cause for the reported complaint could be due to biological debris and protein build up interfering with the device.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.Additional information: "new information was received from physician: the action taken with chpv shunt and siphonguard csf control device was updated from unknown to not applicable.The gender was added as male.The event verbatim device malfunctioning was updated to device malfunctioning/ not working.The event seriousness criteria was added as hospitalization.The indication and concurrent condition were added as normal pressure hydrocephalus.The causality was updated to possible from not reported." "causality for the event device malfunctioning/ not working (shunt malfunction) was possible by the reporter for chpv shunt and siphonguard csf control device." "the case seriousness was reported by the reporter as hospitalization." "this is a serious case regarding a male patient of unspecified age who had shunt malfunction during the use of chpv shunt (codman hakim programmable valve) and siphonguard csf control device for normal pressure hydrocephalus.The causality for the event is considered as not assessable based on nature of the event.However, there is limited information regarding patient age, therapy dates of the suspect drug, onset date and outcome of the reported event, concomitant medication, complete medical history and lab data.As per the company manual of both the suspect drugs, the reported event shunt malfunction is labeled.".
Event or Problem Description
N/a.

• Brand Name: CHPV RT ANG RESERVOIR UNITIZED
• Common Device Name: CHPV
• 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: 20236932
• Report Number: 3013886523-2024-00279
• Device Sequence Number: 20823436
• Product Code: JXG
• UDI-Device Identifier: 10381780519225
• UDI-Public: 10381780519225
• Combination Product (Y/N): N
• PMA/510(K) Number: K221840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 823148
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2024
• Supplement Date Received by Manufacturer: 10/11/2024
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Male