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

Model Number	BG101-350
Medical Device Problem Codes	Break (1069); Device Difficult to Setup or Prepare (1487); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the silicone tubing in baerveldt glaucoma shunt is more weak recently.Additional information was received that the surgeon is still noticing the device has changed and indicated that the tubing is more flimsy.The surgeon has trouble inserting in the sclera tunnel.It was also reported that the implant was fully inserted.In addition, because the tubing is flimsier, it has a tendency to kink.When the surgeon sutures the tubing, because it is so fragile, the suture will cut the tubing which is not normal.Lastly, it was reported that after the surgeon sutured some of the tubing's to fixate it, when they perform the flushing test, it leaks from the micro holes in the tubing.Patient status reported as unknown.No other information was provided.This report is for 3 of the 5 reported events.A separate report is being submitted for each of the 5 products.
Additional Manufacturer Narrative
Section a2, a3a, a3b, a4, a5, a6: information unknown/not provided.Section b3: date of event: unknown/not provided.Section d6a: if implanted, give date: unknown/not reported; it is unknown if the iol had any patient contact or if it was implanted.Section d6b: if explanted, give date: unknown/not reported; it is unknown if the iol had any patient contact or if it was implanted.Section e1: telephone number: (b)(6).Section h3: 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.Section h6: device code of 3191 dissatisfaction - quality/design.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected/additional data: upon further review, it was determined that based on the surgeon's report of "after the surgeon sutured some of the tubing's to fixate it, when they perform the flushing test, it leaks from the micro holes in the tubing." in reviewing the initial mdr, it was noticed that the following information was inadvertently not included, it was reported in an optimal case the tubing should be blocked.Hence, the tube leaks during the flushing test.Therefore, the event is no longer considered a reportable malfunction and no further information will be provided.This report is for 3 of the 5 reported events.A separate correction report is being submitted for each of the 5 products.All pertinent information available to johnson and 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: 19443085
• Report Number: 3012236936-2024-000155
• Device Sequence Number: 7024592
• Product Code: KYF
• UDI-Device Identifier: 05050474512993
• UDI-Public: (01)05050474512993(17)250126
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2024

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: 01/26/2025
• Device Model Number: BG101-350
• Device Catalogue Number: 23030817
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2024
• Supplement Date Received by Manufacturer: 06/07/2024
• Initial Report FDA Received Date: 06/01/2024
• Supplement Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/26/2023
• 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: Unknown