MAUDE Adverse Event Report: GLAUKOS CORPORATION ISTENT TRABECULAR MICRO-BYPASS; INTRAOCULAR PRESSURE LOWERING IMPLANT

Model Number	GTS100L
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for evaluation.The investigation is in progress and findings will be provided in a supplemental report.The device history records were reviewed for this manufacturing lot and there were no non-conformities found to be related to the reported event.As part of the device history records review, the sterilization records for this lot were reviewed and this device lot passed sterility tests.A complaint history lot review was completed for this lot and there were no complaints found to be related to the reported event.Mfr# reference: (b)(4).
Event or Problem Description
It was reported that prior to patient contact, a foreign material was observed in the packaging of an unopened trabecular micro-bypass stent.There was no patient contact as the product was not used.A back-up stent was implanted successfully.
Additional Manufacturer Narrative
Evaluation of the returned device was completed.Visual inspection of the returned device found the tyvek lid unsealed and a foreign material was found between the tray and tyvek lid.In addition, the returned device was functionally tested and found to function as intended.No other non-conformances were found during inspection.Per manufacturing procedure, each device undergoes visual inspection prior to distribution.Based on the results of the investigation, it is possible that the contaminant was introduced in the surgical environment as the returned device was found unsealed.Mfr# reference: (b)(4).

• Brand Name: ISTENT TRABECULAR MICRO-BYPASS
• Common Device Name: INTRAOCULAR PRESSURE LOWERING IMPLANT
• Manufacturer (Section D): GLAUKOS CORPORATION; 229 avenida fabricante; san clemente CA 92672
• MDR Report Key: 7891590
• Report Number: 2032546-2018-00090
• Device Sequence Number: 1837220
• Product Code: OGO
• UDI-Device Identifier: 00853704002012
• UDI-Public: 0100853704002012
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P080030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2018
• Report Date (Section F): 01/01/2005

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: 04/30/2021
• Device Model Number: GTS100L
• Device Catalogue Number: GTS100L
• Device Lot Number: 115454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/27/2018
• Supplement Date Received by Manufacturer: 10/03/2018
• Initial Report FDA Received Date: 09/19/2018
• Supplement Report FDA Received Date: 10/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005