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

Model Number EN29141022

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/24/2020

Event Type  malfunction  

Manufacturer Narrative

The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.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, pump tubing leak (tear).The device was revised.

Event Description

This follow-up mdr is created to document the additional event information received for record #(b)(4).According to the available information the inflatable penile prosthesis was implanted on (b)(6)2016 and revised on (b)(6)2020 due to a leak (tear) in the pump tubing.The device was not received for evaluation.Without the benefit of analyzing the device quality cannot confirm any observations or comment on the condition of the product.If the device becomes available, or additional information is received, the complaint will be re-evaluated according to procedures.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 revealed no trends for this lot.Review of nonconforming reports revealed no nonconformances for this lot.No capas are associated with this lot.

Manufacturer Narrative

Based on the available information, the reported complaint is identified in the risk management documentation and reviewed routinely with management to monitor complaint trends as part of post market surveillance.No corrective action is required at this time.

Manufacturer Narrative

Based on examination of the returned product, it was concluded that the abrasion marks noted on all pump tubing 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 longer pump exhaust tubing kinking onto itself and abrading, resulting in sufficient stress(s) to cause a separation in the longer pump exhaust tubing.A separation of this type could then allow the loss of fluid, rendering the device inoperable.Because these components were released according to manufacturing and quality control procedures, it was concluded that the observed instrument separation in the bladder of cylinder 2 occurred after the device packaging was opened.In addition, because the expected use of this device combined with the observed separation would have resulted in an earlier detected fluid loss, it was concluded that the separation most likely occurred during or after explant.This separation is not associated with the cause for failure.

• Brand Name: TITAN TOUCH
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 10438655
• MDR Text Key: 203905720
• Report Number: 2125050-2020-00757
• 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,foreign,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: EN29141022
• Device Catalogue Number: EN2914
• Device Lot Number: 5120928
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2020
• Date Manufacturer Received: 06/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR