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

Model Number QS89181400

Device Problems Break (1069); Crack (1135)

Patient Problem No Information (3190)

Event Date 12/12/2019

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, a crack on the clear tubing leading from the pump to the cylinders was noted from a device that was implanted some time in 2009.Another inflatable penile prosthesis was implanted.

Manufacturer Narrative

This follow-up mdr is created to document the evaluation of the returned device.A titan pump, two cylinders and detached inlet tube with connector were received for evaluation.Examination and testing of the returned components revealed partial separations within abrasion on the longer exhaust tube of the pump and shorter end of the detached inlet tube with connector.Testing revealed these to not be sites of leakage.Abrasion was also noted on the inlet tube of the pump and exhaust tube of cylinder 1.Microscopic examination of the detachment ends revealed the shorter exhaust tube of the pump and exhaust tube of cylinder 2 to be rough and irregular, indicating stress was exerted.No functional abnormalities were noted with the pump, either cylinder or detached inlet tube with connector.Based on examination of the returned product, it was concluded that while in-vivo both the exhaust tubes and inlet tube of the pump had overlapped and abraded against one another.This positioning, in combination with device usage over time, could most likely contribute to sufficient stress(s) to separate the shorter exhaust tubing.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, nonconformance's and capas revealed no trends for this lot.

• Brand Name: TITAN SCROTAL 18CM
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 9571970
• MDR Text Key: 174472931
• Report Number: 2125050-2020-00035
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 03/13/2020

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: QS89181400
• Device Catalogue Number: QS8918
• Device Lot Number: 3187289
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Initial Date Manufacturer Received: 12/12/2019
• Initial Date FDA Received: 01/09/2020
• Supplement Dates Manufacturer Received: 12/12/2019
• Supplement Dates FDA Received: 03/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR