MAUDE Adverse Event Report: COLOPLAST A/S TITAN TOUCH SCRO ZERO ANG 20CM; INFLATABLE PENILE PROSTHESIS

Model Number ES29202400

Device Problem Material Rupture (1546)

Patient Problem No Information (3190)

Event Date 10/12/2018

Event Type  Injury  

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.

Event Description

According to the available information, the device was explanted due to a tubing break in clear tubing from pump to cylinder (broken slightly above thick tubing).The other clear tubing on the opposite side and the black tubing look worn.

Manufacturer Narrative

This follow-up mdr is created to document the evaluation of the returned device.A pump and two cylinders were received for evaluation.Examination and testing of the returned components revealed a separation in the longer exhaust tube of the pump.Testing revealed this to be a site of leakage.Abrasion is noted surrounding this separation.Partial separations, within abrasion are noted on all tubes of the pump.Testing revealed these to not be sites of leakage.A group of striations, indicating contact with unshod instrumentation, is noted on the exhaust tube of cylinder 2.Testing revealed this to be a site of leakage.Abrasion is noted on the exhaust tubes of both cylinders.No functional abnormalities were noted with cylinder 1.Based on examination of the returned product, 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, resulting in the separation noted on the longer exhaust tube.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, the observed instrument separation 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 separation would have resulted in an earlier detected fluid loss, quality concluded that the separation most likely occurred during or subsequent to explant.This separation is not associated with the cause for failure.

Manufacturer Narrative

Quality was unsuccessful in securing the device for evaluation.Without the benefit of analyzing the device, quality cannot confirm any observations and cannot comment on the condition of the device.If the device becomes available, or additional information is received, quality will re-evaluate this complaint in accordance to procedures.Quality reviewed the manufacturing records for this device and confirmed that there were no discrepancies that would have contributed to this complaint and verified that the devices from this lot met all specifications prior to release.A review of the complaint history database revealed no significant trends for lot 3951064.Review of nonconforming reports revealed no nonconformance's for this lot.No capas are associated with this lot.

• Brand Name: TITAN TOUCH SCRO ZERO ANG 20CM
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 8041824
• MDR Text Key: 126248311
• Report Number: 2125050-2018-00794
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 05708932539197
• UDI-Public: 05708932539197
• 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
• Report Date: 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ES29202400
• Device Catalogue Number: ES2920
• Device Lot Number: 3951064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2019
• Date Manufacturer Received: 10/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR