MAUDE Adverse Event Report: COLOPLAST A/S TITAN OTR SCROTAL 22CM; INFLATABLE PENILE PROSTHESIS

Model Number QSR9221022

Device Problems Pumping Problem (3016); Torn Material (3024)

Patient Problem No Information (3190)

Event Date 11/02/2017

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 the available information, device malfunction - squeezing the pump didn't seem to have any effect on the device, a torn rube was found during the explantation.

Manufacturer Narrative

An otr pump, two cylinders and a reservoir were received for evaluation.Examination and testing of the returned components revealed a separation in the shorter exhaust tube of the pump near the strain relief.Testing revealed this to be a site of leakage.The separation appears to be within an area of confined abrasion.Surface abrasion was noted on both exhaust tubes and the inlet tube.Partial separations were noted within abrasion on the longer exhaust tube of the pump.These were not sites of leakage.A partial separation within abrasion was noted on the inlet tube of the pump.This is not a site of leakage.The pump failed the pump back pressure test.Dried tissue was noted within the pump which may have contributed to the failure.A separation was noted on the lockout valve of the reservoir.This is a site of leakage.The surfaces appeared to have uniform striations, indicating the area was in contact with sharp instrumentation.However, the reservoir passed the valve seating operation test.No abnormalities were noted during examination and testing of cylinders 1 and 2.Based on quality examination, quality concluded that while in-vivo both the exhaust tubes and inlet tube of the pump positioned themselves in such a way that caused them to overlap and abrade against one another.This then most likely caused the shorter exhaust tube to kink onto itself, which caused the tubing to abrade and result in a separation in the tubing.A separation of this type would then allow the loss of fluid, making the device inoperable.Because these components were released according to manufacturing and quality control procedures, quality concluded that the observed instrument separation in the lockout valve of the reservoir occurred subsequent to the device packaging being opened.Because the expected use of this device combined with the observed separation would have resulted in an earlier detected fluid loss, and the reported information indicated a torn tube found during the explantation, quality concluded that the separation most likely occurred during or subsequent to explant.This separation is not associated with the cause for failure.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.

• Brand Name: TITAN OTR SCROTAL 22CM
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: stephanie perryman ; 1601 west river road north; minneapolis, MN 55411 ; 6123024983
• MDR Report Key: 7152094
• MDR Text Key: 95961536
• Report Number: 2125050-2017-00649
• 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
• Report Date: 02/20/2018

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: QSR9221022
• Device Catalogue Number: QSR9221022
• Device Lot Number: 2428216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/14/2017
• Initial Date FDA Received: 12/28/2017
• Supplement Dates Manufacturer Received: 12/14/2017
• Supplement Dates FDA Received: 02/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other