MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS BAERVELDT GLAUCOMA IMPLANT (250); IMPLANT, EYE VALVE

Model Number	BG103250
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age:unknown, information not provided.Date of birth:unknown, information not provided.Weight:unknown, information not provided.Ethnicity:unknown, information not provided.Date of event: (b)(6) 2021 is provided as a best estimate based on source document.Implant date if implanted, give date: not applicable, as shunt was removed/replaced in the initial surgery.Explant if explanted, give date: not applicable, as shunt was removed/replaced in the initial surgery.Mfr site telephone number:(b)(4) attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the glaucoma shunt was defective.The tube split when suture was put through it.There was patient contact.A new shunt was opened and the procedure was completed successfully using it.No further information is available.
Additional Manufacturer Narrative
Correction: upon reviewing the complaint folder, it has been determined that the suture used can be a normal part of the shunt surgery.Suture can be placed to partially occlude the tube initially, so the iop can be monitored post op.If iop stays high, suture can be adjusted or removed to modify how much aqueous the tube is filtering.Hence, based on our reportable criteria, this report is no longer a reportable event.Therefore, an emdr is required to state that no further follow ups will be sent out under medwatch 9614546-2021-07137.G8: correction: in review of medwatch 9614546-2021-07137, this event has been assessed not reportable.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: BAERVELDT GLAUCOMA IMPLANT (250)
• Common Device Name: IMPLANT, EYE VALVE
• Manufacturer (Section D): AMO MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen, groningen 9728 NX; NL 9728 NX
• MDR Report Key: 11721535
• Report Number: 9614546-2021-07137
• Device Sequence Number: 14393964
• Product Code: KYF
• UDI-Device Identifier: 05050474513013
• UDI-Public: (01)05050474513013(17)220904
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K905129
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2021

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: 09/04/2022
• Device Model Number: BG103250
• Device Catalogue Number: 23030819
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/26/2021
• Supplement Date Received by Manufacturer: 07/06/2021
• Initial Report FDA Received Date: 04/24/2021
• Supplement Report FDA Received Date: 07/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1