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

Model Number QNR9161022

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/30/2020

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, tubing fracture 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 otr pump, two cylinders, and a reservoir were received for analysis.Microscopic evaluation revealed partial separations within abrasion on both pump exhaust tubes.Testing revealed these to not be sites of leakage.Microscopic evaluation revealed surface abrasion on all pump tubing, indicating repetitive contact between surfaces.No functional abnormalities were noted with the pump.Microscopic evaluation revealed partial separations within abrasion on the cylinder 2 exhaust tubing.Testing revealed this to not be a site of leakage.Microscopic evaluation revealed surface abrasion on the cylinder 1 and cylinder 2 exhaust tubing.No functional abnormalities were noted on cylinder 1 or cylinder 2.Microscopic evaluation revealed a separation surrounded by partial separations in the reservoir inlet tubing adjacent to the connector.Testing revealed this to be a site of leakage.Based on recreation of the position of the tubes according to the abrasion pattern, this demonstrates that all pump tubes were overlapping in-vivo.This positioning, in combination with device usage over time, could contribute to sufficient stress to cause a separation through the reservoir inlet tubing at this site.A separation of this type could then allow the loss of fluid, rendering the device inoperable.

• Brand Name: TITAN
• Type of Device: INFLATABLE PENILE PROTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 11336558
• MDR Text Key: 232160030
• Report Number: 2125050-2021-00140
• 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: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/13/2017
• Device Model Number: QNR9161022
• Device Catalogue Number: QNR916
• Device Lot Number: 2804847N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2021
• Date Manufacturer Received: 08/02/2021
• Patient Sequence Number: 1
• Patient Age: 77 YR