MAUDE Adverse Event Report: COLOPLAST A/S TITAN INFLATABLE PENILE PROSTHESIS FAMILY; PENILE PROSTHESIS, INFLATABLE

Catalog Number	EN2914
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release.No trends were noted for complaints and there were no nonconforming reports or capas that were confirmed to be associated.
Event or Problem Description
According to the available information the device was explanted and replaced due to a malfunction.
Additional Manufacturer Narrative
Titan touch pump and cylinders 1 and 2 were received for evaluation.Abrasion was noted on both exhaust tubes and the inlet tube of the pump.A separation was noted on the longer exhaust tube of the pump.This was a site of leakage.The surfaces appear to be rough and irregular, indicating stress was exerted.A separation was noted on the bladder of cylinder 1.This is a site of leakage.The separation has a smooth, straight edge, indicating contact with sharp instrumentation.No functional abnormalities were noted with cylinder 2.Based on examination of the returned product, it was concluded that the rough and irregular surfaces associated with the separation indicates that sufficient stress was exerted on the longer exhaust tube of the pump to separate the site while in-vivo.A separation of this type could then allow the loss of fluid, making the device inoperable.Because these components were released according to manufacturing and quality control procedures, it was concluded that the observed instrument separation in the bladder of cylinder 1 occurred after the device packaging was opened.In addition, because the expected use of this device combined with the observed separation would have resulted in an earlier detected fluid loss, it was concluded that the separation most likely occurred during or after explant.This separation is not associated with the cause for failure.A review of the device history record confirmed the devices from this lot met all specifications prior to release.No trends were noted for complaints and there were no nonconforming reports or capas that were confirmed to be associated.
Event or Problem Description
According to the available information the device was explanted and replaced due to a malfunction.

• Brand Name: TITAN INFLATABLE PENILE PROSTHESIS FAMILY
• Common Device Name: PENILE PROSTHESIS, INFLATABLE
• Manufacturer (Section D): COLOPLAST A/S; 1 holtedam humlebaek, dk 3050; humlebaek 3050 ; DA 3050
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 18663760
• Report Number: 2125050-2024-00200
• Device Sequence Number: 12591912
• Product Code: FHW
• UDI-Device Identifier: 05708932539098
• UDI-Public: 05708932539098
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• PMA/510(K) Number: P000006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/18/2025
• Device Catalogue Number: EN2914
• Device Lot Number: 7618602_EN29141022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/07/2024
• Supplement Report FDA Received Date: 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TITAN INFLATABLE PENILE PROSTHESIS ACCESSORIES.; TITAN INFLATABLE PENILE PROSTHESIS ACCESSORIES.; TITAN INFLATABLE PENILE PROSTHESIS ACCESSORIES.; TITAN INFLATABLE PENILE PROSTHESIS ACCESSORIES.; TITAN INFLATABLE PENILE PROSTHESIS FAMILY.; TITAN INFLATABLE PENILE PROSTHESIS FAMILY.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Unknown