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

Catalog Number	QNR916
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the available information the tubing leaked.The device was explanted and replaced.
Additional Manufacturer Narrative
The lot number was reviewed for complaint trend, nonconforming report, and capa.No ncs nor capas were identified.There were 3 complaints identified against this lot; however, with various failure modes.Therefore, this is not considered a trend.Devices met specification prior to release.
Event or Problem Description
According to the available information the tubing leaked.The device was explanted and replaced.
Additional Manufacturer Narrative
Titan otr 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, surrounded by abrasion, was noted on the longer exhaust tube of the pump.This is a site of leakage.Both cylinders were received with tow sutures still attached.No functional abnormalities were noted with cylinder 1 or cylinder 2.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.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 (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: 18068337
• Report Number: 2125050-2023-01352
• Device Sequence Number: 12702464
• Product Code: FHW
• UDI-Device Identifier: 05708932319744
• UDI-Public: 05708932319744
• 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: 2015
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2024

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: 06/21/2020
• Device Catalogue Number: QNR916
• Device Lot Number: 4684263_QNR9161022
• 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: 11/03/2023
• Supplement Report FDA Received Date: 01/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2015
• 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 FAMILY; TITAN INFLATABLE PENILE PROSTHESIS FAMILY
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male