MAUDE Adverse Event Report: GLAUKOS CORPORATION ISTENT INFINITE TRABECULAR MICRO-BYPASS SYSTEM; AQUEOUS SHUNT

Model Number	IS3-WW
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the trocar broke during attempt to implant the first stent from a trabecular microbypass stent system in the patient's right eye (od).Per report, the trocar fragment was removed from the eye intraoperatively, and a back-up device was used to complete the procedure.The report noted the event as "resolved" with no patient injury.Additional information has been requested.
Additional Manufacturer Narrative
Additional information: a6: race noted as chinese.The device was not available; therefore, product testing on the actual device could not be performed.The device history record review of the manufacturing lot was performed and there were no non-conformities found to be related to the reported event.A complaint history review was completed.The electronic complaint system was searched for the specified lot#.There were no similar issues reported for this lot #.A review of the device labeling including the risk analysis was completed.The reported issue (trocar fragmentation) is identified to be an anticipated hazard.The residual risk for each potential harm was found to be within the insignificant risk region.The ifu adequately provides instructions for stent implantation, precautions, and warnings for the proper use and handling of the device.Mfr# reference:(b)(4).

• Brand Name: ISTENT INFINITE TRABECULAR MICRO-BYPASS SYSTEM
• Common Device Name: AQUEOUS SHUNT
• Manufacturer (Section D): GLAUKOS CORPORATION; 229 avenida fabricante; san clemente CA 92672
• Manufacturer (Section G): GLAUKOS CORPORATION; 229 avenida fabricante; san clemente CA 92672
• Manufacturer Contact: brittany massey ; 229 avenida fabricante; san clemente, CA 92672 ; 949367960
• MDR Report Key: 20409225
• Report Number: 2032546-2024-00116
• Device Sequence Number: 9044110
• Product Code: KYF
• UDI-Device Identifier: 00853704002470
• UDI-Public: 01008537040024701032125917260630213
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K220032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/09/2024

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 Expiration Date: 06/30/2026
• Device Model Number: IS3-WW
• Device Lot Number: 321259
• 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: 09/30/2024
• Initial Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/08/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Race: Asian