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

Model Number ES29162400

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/31/2020

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.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, tubing broke at pump exit.Device removed and replaced.

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.

Event Description

This follow-up mdr is created to document the additional event information received for record #605410.According to the available information this inflatable penile prosthesis was implanted on (b)(6) 2016 and removed/replaced on (b)(6) 2020 due to broken pump tubing.Additional information received indicated: ¿tubing broke at pump exit.¿ a titan touch pump, two cylinders, and reservoir were received for evaluation.Examination and testing of the returned components revealed a separation within abrasion on the longer exhaust tube of the pump.Testing revealed this to be a site of leakage.Microscopic examination of the surfaces revealed them to be rough and irregular, indicating stress was exerted.Surface abrasion was noted on all pump tubing and on the exhaust tubing of cylinder 1.No functional abnormalities were noted with the reservoir, cylinders 1 and 2, and the detached inlet tubing.Based on recreation of the position of the tubes according to the abrasion pattern, this demonstrates that the pump tubing was overlapping in-vivo.This positioning, in combination with device usage over time, could contribute to sufficient stress to cause a separation through the longer length of pump exhaust tubing at this site.A separation of this type could 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, nonconformances and capas revealed no trends for this lot.

• 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: 10467554
• MDR Text Key: 204777977
• Report Number: 2125050-2020-00781
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 05708932539173
• UDI-Public: 05708932539173
• 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: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ES29162400
• Device Catalogue Number: ES2916
• Device Lot Number: 4684249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2020
• Date Manufacturer Received: 07/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR