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

Model Number QSR8201400

Device Problems Free or Unrestricted Flow (2945); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/02/2020

Event Type  malfunction  

Manufacturer Narrative

The lot number was reviewed for complaint trend, nonconforming report and capa review.Devices met specification prior to release and 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, there was a left cylinder blow out.The device was removed and replaced.Additional information indicated deflated implant.

Manufacturer Narrative

This follow-up mdr is created to document the corrected device information and the evaluation of the returned device.In addition, the implant date reported in the initial report is incorrect.The correct implant date is unknown.A titan one touch release pump and two cylinders were received for evaluation.An aneurysm was noted in the bladders of cylinders 1 & 2, indicating that enough pressure was generated to aneuryze the site.Testing revealed only the bladder of cylinder 2 to be a site of leakage.The presence of surface abrasion was noted on all strain reliefs and tubing of the pump, along with both exhaust tubes of cylinders 1 and 2.No functional abnormalities were noted with the pump or detached tubing.Based on examination, it was concluded that while in-vivo enough pressure may have been exerted to result in an aneurysm on the bladder of cylinder 2.This pressure, in combination with device usage, could contribute to sufficient stress (s) to separate the bladder 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 revealed no trends for this lot.Review of nonconforming reports revealed no non-conformances for this lot.No capas are associated with this lot.No patient injury was reported.

• Brand Name: TITAN OTR
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 9910548
• MDR Text Key: 188578960
• Report Number: 2125050-2020-00289
• 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,health
• Type of Report: Initial,Followup
• Report Date: 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: QSR8201400
• Device Catalogue Number: QSR820
• Device Lot Number: 2709792
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2020
• Date Manufacturer Received: 03/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 77 YR