MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS BAERVELDT SHUNT; IMPLANT, EYE VALVE

Model Number	BG103-250
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section d9.Device available for evaluation? yes.Returned to manufacturer on: july 25, 2024.Section h3.Device evaluated manufacturer? yes.Device evaluation: product evaluation was performed under magnification.The complaint device presented with a cut off tube.The complaint issue of ¿dc-damaged / broken¿ was identified during product evaluation; however, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.Therefore, there is no indication of a product deficiency or product malfunction.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data: in the initial mdr report, section h10 text it stated "section d6a: if implanted, give date: not applicable, as lens was removed/replaced during the same procedure." then also in section d6b: if explanted, give date: not applicable, as lens was removed/replaced during the same procedure." which were incorrect as suspect product for this event is a glaucoma implant and not a lens.This supplemental correction report is submitted to correct previous information indicated in the initial mdr report.Correct text in h10 should have been: section d6a: if implanted, give date: not applicable, as glaucoma implant was removed/replaced during the same procedure.Section d6b if explanted, give date: not applicable, as glaucoma implant was removed/replaced during the same procedure.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a glaucoma shunt was removed from the patient's left eye due to broken shunt while the customer was trying to tie the tube.It was noted that event was due to a product issue.There was patient contact.The procedure was completed successfully.The glaucoma shunt was replaced with a different shunt.Procedure went well.There was no incision enlargement, vitrectomy, sutures done.The patient is doing fine.No other information was provided.
Additional Manufacturer Narrative
Section a5: unknown/ not provided.Asku.Section d6a: if implanted, give date: not applicable, as lens was removed/replaced during the same procedure.Section d6b: if explanted, give date: not applicable, as lens was removed/replaced during the same procedure.Section h3- no: the device was not returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Attempts have been made to obtain missing information; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: BAERVELDT SHUNT
• Common Device Name: IMPLANT, EYE VALVE
• Manufacturer (Section D): AMO MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen, groningen 9728 NX; NL 9728 NX
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 19715895
• Report Number: 3012236936-2024-000194
• Device Sequence Number: 8778385
• Product Code: KYF
• UDI-Device Identifier: 05050474513013
• UDI-Public: (01)05050474513013(17)250426
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• 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: 04/26/2025
• Device Model Number: BG103-250
• Device Catalogue Number: 23030819
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2024
• Supplement Date Received by Manufacturer: 09/26/2024; 10/09/2024
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 09/26/2024; 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2023
• 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 Sex: Female
• Patient Weight: 56 KG
• Patient Race: White