MAUDE Adverse Event Report: COLOPLAST A/S TITAN SCROTAL ZERO ANG 18CM; INFLATABLE PENILE PROSTHESIS

Model Number ES89182400

Device Problem Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 12/23/2019

Event Type  Injury  

Manufacturer Narrative

The lot number was reviewed for complaint trend, nonconforming reports and capa review.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, leak in tubing on left cylinder, approximately one inch from the cylinder.The device was implanted some time in 2011.Another inflatable device was implanted.

Manufacturer Narrative

This follow-up is created to document the conclusion of the evaluation.A titan pump, two cylinders and a reservoir were received for evaluation.Examination and testing of the returned components revealed a separation within abrasion on the exhaust tube of cylinder 1 at the tube/strain relief junction.Testing revealed this to be a site of leakage.Partial separations were noted on the exhaust tube of cylinder 1 and inlet tube of the pump.Testing revealed these to not be sites of leakage.Abrasion was noted on the strain relief of cylinder 1 and all tubes of the pump.A group of striations, indicating contact with unshod instrumentation, was noted on the exhaust tube of cylinder 2.Testing revealed this to be a site of leakage.No functional abnormalities were noted with the pump or reservoir.Based on examination of the returned product, it was concluded that the abrasion marks noted on all pump tubing matched in such a way to conclude that they had overlapped and abraded against one another while in-vivo.The abrasion noted on the exhaust tube of cylinder 1 indicated the tubing had most likely abraded against the cylinder bladder.This positioning, in combination with device usage over time, could most likely contribute to sufficient stress(s) to separate the exhaust tubing of cylinder 1.A separation of this type would then allow the loss of fluid, making the device inoperable.Because these components were released according to manufacturing and quality control procedures, it was concluded that the observed instrument separations in the exhaust tube of cylinder 2 occurred subsequent to the device packaging being opened.In addition, because the expected use of this device combined with the observed separations would have resulted in an earlier detected fluid loss, it was concluded that the separations most likely occurred during or subsequent to explant.These separations are not associated with the cause for failure.A review of the device history record confirmed the devices from this lot met all specifications prior to release.A review of the complaint history database, nonconformances and capas revealed no trends for this lot.

• Brand Name: TITAN SCROTAL ZERO ANG 18CM
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 9619449
• MDR Text Key: 176107106
• Report Number: 2125050-2020-00077
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 05708932487344
• UDI-Public: 05708932487344
• 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
• Type of Report: Initial,Followup
• Report Date: 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ES89182400
• Device Catalogue Number: ES8918
• Device Lot Number: 3522876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2019
• Date Manufacturer Received: 12/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR