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

Model Number ES29181022

Device Problem Material Rupture (1546)

Patient Problem Failure of Implant (1924)

Event Date 11/13/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the available information, though not verified, first implantation in 2018, at the beginning of (b)(6) 2020 titan stopped working.Information received on 11/17/2020: titan stopped working when pumping up the pump.Damage of the tube near the left cylinder.Reservoir left with patent.Removed and replaced.A new, larger sized titan was implanted.The lot # was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.

Manufacturer Narrative

A titan touch pump and two cylinders were received for evaluation.Examination and testing of the returned components revealed a separation in the cylinder 1 tubing at the tubing/strain relief junction.Testing revealed this to be a site of leakage.Microscopic evaluation revealed the surfaces to be rough and irregular, indicating sufficient stress was exerted to separate the site.Microscopic evaluation revealed surface abrasion on all pump tubing, and the cylinder 2 exhaust tubing.No functional abnormalities were noted with the pump or cylinder 2.Based on examination of the returned product, it was concluded that the abrasion marks noted on all pump tubing indicated that tubing may have overlapped and abraded against one another while in-vivo.This positioning, in combination with device usage over time, may have contributed sufficient stress(s) to cause the cylinder 1 exhaust tubing to separate the site while in-vivo.A separation of this type may then allow the loss of fluid, rendering the device inoperable.A review of the device history record confirmed the devices from this lot met all specifications prior to release and no anomalies were noted during production.A review of the complaint history database, non-conformances and capas revealed no trends for this lot.

• Brand Name: TITAN TOUCH
• Type of Device: INFLATABLE PENILE PROTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 10988947
• MDR Text Key: 220959178
• Report Number: 2125050-2020-01253
• Device Sequence Number: 1
• Product Code: FHW
• 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
• Report Date: 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/27/2022
• Device Model Number: ES29181022
• Device Catalogue Number: ES2918
• Device Lot Number: 5684014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Date Manufacturer Received: 03/04/2021
• Patient Sequence Number: 1
• Patient Age: 52 YR