MAUDE Adverse Event Report: COLOPLAST A/S TITAN TOUCH SCRO ZERO ANG 22CM; INFLATABLE PENILE PROSTHESIS

Model Number ES29222400

Device Problems Break (1069); Crack (1135)

Patient Problem No Information (3190)

Event Date 05/09/2019

Event Type  Injury  

Manufacturer Narrative

A review of the complaint history database revealed no trends for this lot.Review of nonconforming reports revealed no nonconformances for this lot.No capas are associated with this lot.Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event Description

According to the available information, cracked tubing at pump hub.

Manufacturer Narrative

This follow-up mdr is created to document the evaluation of the returned device.A titan touch pump, two cylinders and a reservoir were received for evaluation.Examination and testing of the returned components revealed a separation with abrasion adjacent to it on the shorter exhaust tube of the pump.Testing revealed this to be a site of leakage.A small leakage area was noted on the exhaust tube of cylinder 1 near the connector site.Microscopic examination of the area could not determine what may have resulted in the minimal leakage noted.A separation/void was noted in the bladder of cylinder 2.Testing revealed this to be a site of leakage.The separation/void was missing material in a full circle shape and the surfaces appeared to be smooth, indicating contact with sharp instrumentation.Another separation was noted on the bladder of cylinder 2 near the base.Testing revealed this to be a site of leakage.Microscopic examination of the surfaces revealed them to have a melted appearance, indicating contact with cauterizing instrumentation.Abrasion was noted on both exhaust tubes of the pump.No functional abnormalities were noted with the reservoir.Based on examination of the returned product, it was concluded that the abrasion marks noted on both exhaust tubes of the pump matched in such a way to conclude that they had overlapped and abraded against one another while in-vivo.This then may have caused the shorter exhaust tube to be kinked onto itself for a period of time.This positioning, in combination with device usage over time, could contribute to sufficient stress(s) to separate the exhaust tubing at this site.A separation of this type would then allow the loss of fluid, making the device inoperable.A small leakage site was noted on the exhaust tube of cylinder 1 near the connector.However, examination could not confirm what may have resulted in the minimal leakage noted.Because these components were released according to manufacturing and quality control procedures, quality concluded that the observed instrument separations in the bladder 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 these 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 TOUCH SCRO ZERO ANG 22CM
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 8745750
• MDR Text Key: 149556815
• Report Number: 2125050-2019-00509
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 05708932539203
• UDI-Public: 05708932539203
• Combination Product (y/n): N
• PMA/PMN Number: P000006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ES29222400
• Device Catalogue Number: ES2922
• Device Lot Number: 5673524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2019
• Date Manufacturer Received: 05/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 46 YR