MAUDE Adverse Event Report: COLOPLAST A/S TITAN OTR NAR SCRO 14CM; INFLATABLE PENILE PROSTHESIS

Model Number QNR9141022

Device Problems Fracture (1260); Leak/Splash (1354); Material Rupture (1546)

Patient Problems No Information (3190); No Code Available (3191)

Event Date 01/22/2018

Event Type  Injury  

Manufacturer Narrative

Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information of conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event Description

According to available information, titan otr was explanted due to tubing fracture and leakage.

Manufacturer Narrative

Quality was unsuccessful in securing the explanted prosthesis for evaluation.Without the benefit of analyzing the explant, quality cannot confirm any observations and cannot comment on the condition of the prosthesis.If the explanted device becomes available, or additional information is received, quality will re-evaluate this complaint in accordance to procedures.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.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, and because the device is not available for evaluation, no further corrective action is required at this time.

Manufacturer Narrative

This follow-up mdr is created to document the evaluation of the returned device.A titan otr pump, two cylinders, and a reservoir were received for evaluation.Examination and testing of the returned components revealed a separation in the exhaust tube of cylinder #2.Testing revealed this to be a site of leakage.The separation appears to be smooth and non-striated, indicating sufficient stress was exerted.Surface abrasion is noted on all tubes and strain relief of the pump, on the exhaust tube of cylinder #1 and cylinder #2, and on the inlet tube and strain relief of the reservoir.Partial separations within abrasion are noted on the inlet tube of the reservoir.Testing revealed these not to be sites of leakage.No functional abnormalities are noted with the pump, cylinder #1, or the reservoir.Based on quality's examination, quality concluded that while in-vivo both the exhaust tubes and inlet tube positioned themselves in such a way that caused them to overlap and abrade against one another.Quality further concluded that this positioning, in combination with device usage over time, could contribute to sufficient stress(s) to separate the exhaust tube of cylinder #2 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.A review of the complaint history database revealed no additional complaints of this type for lot 3571770.Review of nonconforming reports revealed no nonconformance's for this lot.No capas are associated with this lot.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 OTR NAR SCRO 14CM
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 7264567
• MDR Text Key: 99844846
• Report Number: 2125050-2018-00102
• 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: distributor,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 06/27/2018

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: QNR9141022
• Device Catalogue Number: QNR9141022
• Device Lot Number: 3571770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/24/2018
• Initial Date FDA Received: 02/12/2018
• Supplement Dates Manufacturer Received: 01/24/2018; 01/24/2018
• Supplement Dates FDA Received: 04/10/2018; 06/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 49 YR