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

Model Number ES29222400

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 09/12/2019

Event Type  Injury  

Manufacturer Narrative

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, the system was empty of fluid.It was reported the device had cracked tubing near the pump.Only the pump was explanted and replaced.

Manufacturer Narrative

This follow-up mdr is created to document the additional event information and evaluation of the returned device.A titan touch pump was received for evaluation.Examination and testing of the returned component revealed a separation within abrasion on the shorter exhaust tube of the pump.Testing revealed this to be a site of leakage.Abrasion was noted on the longer exhaust tube and inlet tube of the pump.Based on recreation of the position of the tubes according to the abrasion pattern, this demonstrates that all pump tubes were overlapping one another while in-vivo.This positioning, in combination with device usage over time, could contribute to sufficient stress(s) to cause a separation through the shorter exhaust tubing at this site.A separation of this type would then allow the loss of fluid, making the device inoperable.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, non-conformances and capas revealed no trends for this lot.

Event Description

Additional information indicated the crack was in the tubing leading from the pump to the cylinder.

• 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: 9181803
• MDR Text Key: 162042894
• Report Number: 2125050-2019-00850
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 3851440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2019
• Initial Date Manufacturer Received: 09/12/2019
• Initial Date FDA Received: 10/11/2019
• Supplement Dates Manufacturer Received: 09/12/2019
• Supplement Dates FDA Received: 12/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR