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

Model Number 5177801400

Device Problems Crack (1135); Material Rupture (1546)

Patient Problems Failure of Implant (1924); No Information (3190)

Event Date 02/01/2018

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 the available information, titan otr was explanted due to crack in tubing going from pump to cylinder.

Manufacturer Narrative

An otr pump, two cylinders and a reservoir were received for evaluation.Examination and testing of the returned components revealed a separation of the tubing near the strain relief of cylinder 2.Testing revealed this to be a site of leakage.The separation appeared to be rough and irregular, indicating sufficient stress was exerted to separate the site.Surface abrasion is noted on all tubes of the pump and cylinders.Visual examination of the reservoir revealed a small aneurism.Testing revealed this not to be a site of leakage.No functional abnormalities are noted with the reservoir and cylinder 1.Tissue is noted in the pump.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.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: PUMP OTR
• 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: 7314388
• MDR Text Key: 101536445
• Report Number: 2125050-2018-00184
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 05708932319744
• UDI-Public: 05708932319744
• Combination Product (y/n): N
• PMA/PMN Number: P000006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 5177801400
• Device Catalogue Number: 5177801400
• Device Lot Number: 3224707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/07/2018
• 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
• Patient Age: 69 YR