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

Model Number ES89202400

Device Problems Inflation Problem (1310); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/06/2020

Event Type  malfunction  

Manufacturer Narrative

The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.The device has been received at coloplast; however the evaluation is not yet complete.Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Once our evaluation is complete, a follow-up report will be submitted.

Event Description

According to the available information, the prosthesis was no longer working.The patient reported hearing a popping sound upon trying to inflate and is no longer able to inflate the device.When pressing the pump a noticeable "whoosing" sound was reported without inflation.On a later date, a revision surgery occurred.Only the pump was removed.There were no other reported contributing issues.

Manufacturer Narrative

A titan pump was received for evaluation.Examination and testing of the returned component revealed a separation in the pump bulb between the first and second rib.Testing revealed this to be a site of leakage.Microscopic examination of the surfaces revealed them to be rough and irregular, indicating stress was exerted.Microscopic examination revealed surface abrasion on the pump inlet tube, indicating repetitive contact between surfaces.Based on examination of the returned product, it was concluded that the rough and irregular surfaces associated with the separation in the pump bulb indicates that sufficient stress(s) may have been exerted on the pump to separate the site while in-vivo.A separation of this type would 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 and no abnormalities were noted with material or during production.A review of the complaint history database, non-conformances and capas revealed no trends for this lot.

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

This follow-up mdr is created to document the additional event information received for record (b)(6).According to the available information this inflatable penile prosthesis was implanted on (b)(6) 2019 and revised on (b)(6) 2020 due to a the device not working.Management routinely reviews events such as this and monitors complaint levels.Additionally, events of this type are captured in the product risk documentation.Based on this information no further corrective action is required at this time.

• Brand Name: TITAN
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 10216882
• MDR Text Key: 197749751
• Report Number: 2125050-2020-00509
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 05708932487368
• UDI-Public: 05708932487368
• Combination Product (y/n): N
• PMA/PMN Number: P000006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ES89202400
• Device Catalogue Number: ES8920
• Device Lot Number: 7045701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2020
• Date Manufacturer Received: 06/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR