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

Catalog Number	EN2916
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2024
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 in veeva to be associated.
Event or Problem Description
According to the available information, the device was prepped and cycled on the back table with no leaks or issues noted.The device was then implanted and seated proximally where the patient had thick plaque from peyroine's disease.The corporotomy was then sutured closed; however, when the device was cycled again, blood was seen in the syringe indicating a leak.The corporotomy was then opened back up and the device was removed.A leak was identified at the juncture of the narrow base tubing.
Event or Problem Description
According to the available information, the device was prepped and cycled on the back table with no leaks or issues noted.The device was then implanted and seated proximally where the patient had thick plaque from peyronie's disease.The corporotomy was then sutured closed; however, when the device was cycled again, blood was seen in the syringe indicating a leak.The corporotomy was then opened back up and the device was removed.A leak was identified at the juncture of the narrow base tubing.
Additional Manufacturer Narrative
Titan touch pump and cylinders 1 and 2 were received for evaluation.No functional abnormalities were noted with the pump.A separation was noted on the exhaust tubing of cylinder 1 at the strain relief junction.This was a site of leakage.The surfaces appear to be rough and irregular, indicating stress was exerted.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 strain relief of cylinder 1 to separate the site while in-vivo.A separation of this type could then allow the loss of fluid, making the device inoperable.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.

• 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: 19558011
• Report Number: 2125050-2024-00907
• Device Sequence Number: 11974447
• Product Code: FHW
• UDI-Device Identifier: 05708932072557
• UDI-Public: 05708932072557
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P000006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2024

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: Health Professional
• Device Expiration Date: 04/20/2026
• Device Catalogue Number: EN2916
• Device Lot Number: 7988099_EN29162400
• 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: 06/18/2024
• Supplement Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2021
• 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: 57 YR
• Patient Sex: Male