MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES IMPLANTS S.A. OSVII, CONNECTOR WITH ANTECHAMBER.; N/A

Catalog Number 909712

Device Problem Obstruction of Flow (2423)

Patient Problems High Blood Pressure/ Hypertension (1908); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

The device was not yet returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A distributor reported on behalf of the customer that a (b)(6) year-old male patient was implanted with the 909712 osvii connector with antechamber as treatment of hydrocephalus on (b)(6) 2018.The patient then presented with symptoms of intracranial hypertension in (b)(6) 2018.A resonance examination revealed hypertension with ventricular enlargement.On (b)(6) 2019, the team opted for withdrawal of the system and it was replaced with the strata programmable valve.According to the doctor¿s report, both catheters (proximal and distal) were unobstructed.Additional information was received on (b)(6) 2019 indicating that the patient was well after the device replacement procedure.

Manufacturer Narrative

The device history records review did not reveal any anomaly that could explain the reported event.No similar complaint was received for a product from this batch.The valve was tested and found within pressure/flow specifications.The complaint is not verified.Patient presented with intracranial hypertension 4 months after implantation: given the valve testing results, it is possible that the valve was not draining enough for the patient needs, or the valve was indeed obstructed by some residues that were displaced during further valve manipulations (explantation, decontamination or transport).The exact cause of the reported underdrainage could not be determined by the investigation.Device identifier (b)(4).

Event Description

N/a.

• Brand Name: OSVII, CONNECTOR WITH ANTECHAMBER.
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA NEUROSCIENCES IMPLANTS S.A.; 2905 route des dolines; 2905 route des dolines; sophia antipolis
• MDR Report Key: 8403633
• MDR Text Key: 138230324
• Report Number: 9612007-2019-00013
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K081773
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Type of Report: Initial,Followup
• Report Date: 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 909712
• Device Lot Number: 206565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2019
• Date Manufacturer Received: 04/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR