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

Model Number ER80751022

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/13/2021

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, cylinder tubing leak (tear) 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 and two cylinders were received for analysis.Microscopic evaluation revealed surface abrasion on the longer pump exhaust tubing and pump inlet tubing, indicating repetitive contact between surfaces.No functional abnormalities were noted with the pump.A separation was noted in the cylinder 1 exhaust tubing adjacent to the strain relief.Microscopic evaluation revealed confined abrasion, indicating the tubing had been kinked and abrading against itself over a period of time.Testing revealed this to be a site of leakage.Based on examination of the returned product, it was concluded that the abrasion marks noted on the longer pump exhaust tubing and pump inlet tubing indicated they may have overlapped and abraded against one another while in-vivo.This positioning, in combination with device usage over time, may have contributed to the cylinder 1 exhaust tube kinking onto itself and abrading, resulting in sufficient stress(s) to cause a separation of the cylinder 1 exhaust tubing adjacent to the cylinder 2 tubing/strain relief.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: 11336608
• MDR Text Key: 232159623
• Report Number: 2125050-2021-00143
• 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: 05/31/2019
• Device Model Number: ER80751022
• Device Catalogue Number: ER8075
• Device Lot Number: 4162321
• 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: 52 YR