MAUDE Adverse Event Report: COLOPLAST A/S TITAN INFRA ZERO ANG 14CM; INFLATABLE PENILE PROSTHESIS

Model Number	ES88142400
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	11/04/2017
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 available information, titan was explanted due to tear in pump.
Additional Manufacturer Narrative
This follow-up mdr is created to document the evaluation of the returned device and the additional implant date and event information received.A titan pump was received for evaluation.Examination and testing of the returned component revealed a separation in the bulb of the pump.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 of the pump, and on both pieces of detached exhaust tubing.Partial separations within abrasion are noted on the piece of detached inlet tubing.Testing revealed these not to be sites of leakage.No functional abnormalities are noted with the three pieces of detached connector tubing.Based on previous quality simulations and examination of the returned product, quality concluded that the smooth and non-striated surfaces associated with this separation indicates that sufficient stress(s) was exerted on the bulb of the pump to separate the site while in-vivo.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.
Event or Problem Description
According to available information, titan was explanted due to tear in pump.Additional information received indicated patient complaint of implant not functioning.
Additional Manufacturer Narrative
This follow-up mdr is created to document the correct implant/explant dates.

• Brand Name: TITAN INFRA ZERO ANG 14CM
• Common Device Name: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 7265547
• Report Number: 2125050-2018-00172
• Device Sequence Number: 1316734
• Product Code: FHW
• UDI-Device Identifier: 05708932487160
• UDI-Public: 05708932487160
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P000006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/02/2020

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: ES88142400
• Device Catalogue Number: ES88142400
• Device Lot Number: 4326719
• 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: 11/14/2017
• Supplement Date Received by Manufacturer: 11/14/2017; 11/14/2017
• Initial Report FDA Received Date: 02/12/2018
• Supplement Report FDA Received Date: 04/24/2018; 06/05/2020
• 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: 30 YR