MAUDE Adverse Event Report: COLOPLAST A/S ALPHA I SCROTAL; PENILE PROSTHESIS, INFLATABLE

Lot Number 0768384_5187401000

Device Problem Failure to Deflate (4060)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/19/2023

Event Type  Injury  

Manufacturer Narrative

The lot number was reviewed for complaint trend.No trends were noted for complaints.

Event Description

According to the available information the device was explanted and replaced due to the patient could not deflate the device.

Event Description

According to the available information the device was explanted and replaced due to the patient could not deflate the device.

Manufacturer Narrative

Titan pump, cylinders 1 and 2, and reservoir were received for evaluation.Abrasion was noted on both exhaust tubes and the inlet tube of the pump.The surfaces of the detachment site of the shorter exhaust tube of the pump appear to be rough and irregular, indicating stress was exerted.Abrasion was noted the exhaust tube of cylinder 2.No functional abnormalities were noted with either cylinder 1 or cylinder 2.A separation was noted on the bladder of the reservoir.This is a site of leakage.The separation surfaces appear to have varying degrees of degradation.Based on examination of the returned product, it was concluded that while in-vivo both the exhaust tubes and inlet tube of the pump had overlapped and abraded against one another.While no functional abnormalities were noted during testing with the returned components, microscopic examination of the surfaces of the exhaust tube detachment end between the pump and cylinder 2 revealed rough and irregular surfaces, indicating stress was exerted.Based on the overlapping of the pump tubes, in combination with device usage over time, this could contribute to sufficient stress to separate the exhaust tubing of the pump.A separation of this type would then allow the loss of fluid, making the device inoperable.These components were released according to manufacturing and quality control procedures.The device was functioning properly for over 23 years in the patient.Material degradation occurred and progressed enough to cause mechanical failure to take place on the reservoir bladder.Occurrences of this nature are estimated to be relatively rare, and immune responses and in vivo reactions within the human body may largely influence causes for this type of event.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.

• Brand Name: ALPHA I SCROTAL
• Type of Device: 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: 18525295
• MDR Text Key: 333026928
• Report Number: 2125050-2024-00089
• Device Sequence Number: 1
• Product Code: FHW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 0768384_5187401000
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male