FDA Adverse Event Injury Summary report: N

ITRACK ADVANCE

MDR report key: 19915816 · Received August 6, 2024

Report

Report Number: 3005641545-2024-00020
Event Type: Injury
Date Received: August 6, 2024
Date of Event: July 12, 2024
Report Date: August 6, 2024
Manufacturer: NOVA EYE, INC.
Product Code: MPA
PMA / PMN Number: K221872
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: 117

Narratives

Additional Manufacturer Narrative · 0

REVIEW OF PRODUCTION RECORDS SHOW LOT# 2404-10 WAS BUILT USING APPROVED MATERIALS AND RELEASE PROCEDURES WERE CARRIED OUT BY A TRAINED OPERATOR. NO ANOMALIES WERE REPORTED IN THE PRODUCTION RECORD. NOVA EYE IS AWAITING RETURN OF THE DEVICE TO INSPECT IT. THE SURGEON USED NORMAL WELL UNDERSTOOD PROCESSES TO INTRAOPERATIVELY REMOVE THE CATHETER SHEATH. THE SURGEON USED AN ALTERNATIVE PROCEDURE TO COMPLETE THE GLAUCOMA TREATMENT. THIS DID NOT RESULT IN ADDITIONAL RISK TO THE PATIENT. GATT IS A SURGICAL PROCEDURE TO REDUCE THE PATIENT IOP AND INVOLVES DISRUPTION OF THE TRABECULAR MESHWORK. DISRUPTION OF THE TRABECULAR MESHWORK IS ROUTINELY CARRIED OUT AS PART OF CANALOPLASTY PROCEDURES WITH THE ITRACK ADVANCE. 'TRABECULAR MESHWORK RUPTURE' IS CURRENTLY LISTED IN THE PRODUCT INSTRUCTIONS FOR USE AS A POTENTIAL ADVERSE EVENT.

Description of Event or Problem · 0

THE OUTER TUBING OF THE CATHETER BROKE AWAY FROM MAIN DEVICE DURING USE. THE SURGEON USED A SPATULA TO REMOVE THE DETACHED CATHETER PARTS FROM THE PATIENT'S EYE. AS A RESULT OF THE DEVICE BREAKAGE, THE SURGEON ALTERNATIVELY PERFORMED A 180-DEGREE GATT TO COMPLETE THE CASE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1674588	ITRACK ADVANCE	CANALOPLASTY MICROCATHETER KIT WITH ADVANCED DELIVERY SYSTEM	MPA	NOVA EYE, INC.	ITRACK-ADS	2404-10

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown	Required Intervention