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

Catalog Number	823148
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Headache (1880); Vomiting (2144); Ambulation or Postural Difficulties (2544)
Date of Event	04/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported that a hakim valve/chpv rt ang reservoir unitized (id (b)(6)) was implanted via right ventricular peritoneal (vp) shunt on (b)(6) 2023, due to hydrocephalus.A shunt blockage was observed as the patient experienced headache, vomiting, gait imbalance, and urinary incontinence for a week.As a result, shunt revision was performed on (b)(6) 2024.The physician was unable to discern an obvious reason for the shunt malfunction but presumed it was a blocked valve possible caused by micro-debris.It was later reported that the causality for the reported events was not assessable due to lack of information on co-suspect drugs, concomitant medications, complete medical history and relevant lab investigations.However, concurrent condition hydrocephalus could be confounding for the events vomiting, headache, gait disturbance and urinary incontinence.
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 health effect - clinical code 1: e232402.
Additional Manufacturer Narrative
The hakim valve/chpv rt ang reservoir unitized (id 823148) was not returned for evaluation after three good faith attempts (gfes) were made.Lot number information has been provided; device history record (dhr) was reviewed, and no anomalies related to the reported event were found.A possible root cause for the reported issue 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.
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: 19273784
• Report Number: 3013886523-2024-00133
• Device Sequence Number: 7494998
• Product Code: JXG
• UDI-Device Identifier: 10381780534563
• UDI-Public: 10381780534563
• Combination Product (Y/N): N
• PMA/510(K) Number: K053107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2024

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 Catalogue Number: 823148
• Device Lot Number: 7075991
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2024
• Supplement Date Received by Manufacturer: 05/28/2024
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/06/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 32 YR
• Patient Sex: Female