MAUDE Adverse Event Report: COLOPLAST A/S TITAN SCROTAL ZERO ANG 20CM; INFLATABLE PENILE PROSTHESIS

Model Number ES89202400

Device Problem Hole In Material (1293)

Patient Problem No Information (3190)

Event Date 05/18/2018

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 patient found pump would not inflate cylinders - explanted implant found to have a small hole in tubing from pump to cylinders.

Manufacturer Narrative

A titan pump and two cylinders were received for evaluation.Examination and testing of the returned components revealed a separation in the longer exhaust tube of the pump near the strain relief.Testing revealed this to be a site of leakage.The separation appeared to be rough and irregular, which indicates sufficient stress(s) was exerted to separate the site.Partial separations within abrasion were noted on both exhaust tubes of the pump and on the exhaust tube of cylinder 2.Testing revealed these not to be sites of leakage.Surface abrasion was noted on the exhaust tube of cylinder 1.No functional abnormalities were noted with the pump or cylinders 1 and 2.Quality's recreation of the position of the tubes according to the abrasion pattern demonstrates that the longer exhaust tube was overlapping the shorter exhaust tube of the pump.Quality further concluded that this positioning, in combination with device usage over time, could contribute to sufficient stress(s) to cause a separation through the longer exhaust tubing at this site.A separation of this type would then allow the loss of fluid, making the device inoperable.Quality reviewed the manufacturing records for this device and confirmed that there were no discrepancies that would have contributed to this complaint and verified that the devices from this lot met all specifications prior to release.Review of nonconforming reports revealed no nonconformance with this lot that would have contributed to the event.A review of the complaint database revealed no significant trends in complaints of this type for lot 3264303.Management routinely reviews events such as this and monitors complaint levels.Additionally, events of this type are captured in the product risk documentation.Based on this information, no further corrective action is required at this time.

• Brand Name: TITAN SCROTAL ZERO ANG 20CM
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 7586233
• MDR Text Key: 110587759
• Report Number: 2125050-2018-00439
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 05708932487368
• UDI-Public: 05708932487368
• 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: 07/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ES89202400
• Device Catalogue Number: ES89202400
• Device Lot Number: 3264303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR