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

Model Number	5177801400
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Failure of Implant (1924); No Information (3190)
Date of Event	02/01/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
According to the available information, titan otr was explanted due to crack in tubing going from pump to cylinder.
Additional 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
• Common Device Name: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 7314388
• Report Number: 2125050-2018-00184
• Device Sequence Number: 1893225
• Product Code: FHW
• UDI-Device Identifier: 05708932319744
• UDI-Public: 05708932319744
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P000006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2018

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 02/07/2018
• Supplement Date Received by Manufacturer: 02/07/2018
• Initial Report FDA Received Date: 03/05/2018
• Supplement Report FDA Received Date: 04/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR