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

Catalog Number ES2916

Device Problems Fracture (1260); Material Frayed (1262); Material Split, Cut or Torn (4008)

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

Event Type  Injury  

Event Description

Method: the study population consisted of (i) men who had had 3-piece inflatable penile implant surgery (ii) with device malfunction (iii) resulting from pump malfunction (iv) who had all other components functional (v) who underwent pump replacement alone and (vi) had 5 years follow-up after device repair (clinic visit, telephone call, letter).Only patients who had undergone a single prior implant operation were included.At the time of the repair, the pump was removed and replaced with a new pump, making sure that both cylinders and reservoir were filled fully intraoperatively and retained all fluid that was instilled.At the postoperative appointment, all patients were retrained in the correct means of device inflation, specially focused on avoidance of pump torqueing.Results: 88 patients had pump tubing blow-out upon delivery of the pump at a mean duration post-primary implant of 9 11 (2-16) years.Mean age 62 14 years.All patients had either a mentor alpha-1 or a coloplast titan devices placed.Tubing disruption was present 1cm from pump itself in 66 (75%) or >1cm from the pump in 22 (20%) patients.25% had a blow out of the pump-reservoir tubing, while 66 (75%) had a tear in the pump-cylinder tubing (46 frayed tubing, 20 compete transection), evenly distributed between right and left-sided tubing.With a mean follow-up of 72.5 years, none of the devices had failed again.Conclusion: in patients with a malfunctioning penile implant with proven pump-only failure, replacing the pump is a viable repair option, thus, circumventing the need for reservoir placement.

Manufacturer Narrative

Title: 3-piece inflatable penile implant pump malfunction: management using pump replacement alone author(s): hisanori taniguchi*, john sullivan, jose flores, carolyn salter, helen bernie, lawrence jenkins, john mulhall.

• Brand Name: TITAN INFLATABLE PENILE PROSTHESIS FAMILY
• 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: 18606681
• MDR Text Key: 334099896
• Report Number: 2125050-2024-00156
• 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
• Report Date: 01/30/2024

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: ES2916
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/30/2024
• Is the Device Single Use?: 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 Sex: Male