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

Catalog Number	E17926
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the available information the implant was explanted and replaced due to a tubing break.
Additional Manufacturer Narrative
Titan touch, cylinder 2, reservoir, and detached exhaust tubing were received for evaluation.Abrasion was noted on both exhaust tubes and the inlet tube of the pump.No functional abnormalities were noted with the pump.A separation, surrounded by abrasion, was noted on the exhaust tubing of cylinder 2.This was a site of leakage.No functional abnormalities were noted with the reservoir.No functional abnormalities were noted with the piece of detached exhaust tubing.Based on examination of the returned product, it was concluded that the abrasion marks noted on both exhaust tubes and inlet tube of the pump matched in such a way to conclude that they had overlapped and abraded against one another while in-vivo enough to cause a separation in the cylinder 2 exhaust tubing.A separation of this type could then allow the loss of fluid, making the device inoperable.It should be noted that this case is considered off-label, as it is not per indication in the instructions for use (ifu).A review of the device history record confirmed the devices from this lot met all specifications prior to release.A review of the complaint history database, nonconformances and capas revealed no trends for this lot.
Event or Problem Description
According to the available information the implant was explanted and replaced due to a tubing break.

• 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 (Section G): MINNEAPOLIS; 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: 18312406
• Report Number: 2125050-2023-01560
• Device Sequence Number: 6643587
• Product Code: FHW
• UDI-Device Identifier: 05708932487443
• UDI-Public: 05708932487443
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P000006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2024

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: 01/27/2025
• Device Catalogue Number: E17926
• Device Lot Number: 7289304_E179262400
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 02/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 24 YR
• Patient Sex: Unknown