MAUDE Adverse Event Report: COLOPLAST A/S TITAN NARROW INFRA 16CM; INFLATABLE PENILE PROSTHESIS

Model Number	QN88161400
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number was reviewed for complaint trend, nonconforming report and capa review.No trends were noted.The device has been received at coloplast; however the evaluation is not yet complete.Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Once our evaluation is complete, a follow-up report will be submitted.
Event or Problem Description
According to the available information, there was separation noted in the pump bulb.The device was replaced with another inflatable prosthesis.
Additional Manufacturer Narrative
This follow-up was created to document the conclusion of the investigation.A titan pump, two cylinders and a reservoir were received for evaluation.Examination and testing of the returned components revealed a separation in the pump bulb near the adhesive line.Testing revealed this to be a site of leakage.Microscopic examination of the surfaces revealed them to be rough and irregular, indicating stress was exerted.A separation with abrasion adjacent to it was noted on the inlet tube of the reservoir at the tube/strain relief junction.Testing revealed this to be a site of leakage.Abrasion was noted on the longer exhaust and inlet tubes of the pump.Not all testing could be performed on the pump due to the separation noted.No functional abnormalities were noted with either cylinder.Based on examination of the returned product, it was concluded that the rough and irregular surfaces associated with the separation in the pump bulb indicates that sufficient stress(s) may have been exerted on the pump to separate the site while in-vivo.In addition, the abrasion mark noted adjacent to the separation on the reservoir inlet tube indicated the inlet tube had kinked onto itself for a period of time.This positioning, in combination with device usage over time, could contribute to sufficient stress(s) to separate the reservoir inlet tubing.Separations of these types would then allow the loss of fluid, making the device inoperable.A review of the device history record confirmed the devices from this lot met all specifications prior to release.A review of the complaint history database, nonconformances and capas revealed no trends for this lot.

• Brand Name: TITAN NARROW INFRA 16CM
• Common Device Name: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 9662234
• Report Number: 2125050-2020-00109
• Device Sequence Number: 14052391
• Product Code: FHW
• UDI-Device Identifier: 05708932322348
• UDI-Public: 05708932322348
• 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 Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2020

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: QN88161400
• Device Catalogue Number: QN8816
• Device Lot Number: 5491298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2020
• Initial Date Received by Manufacturer: 01/08/2020
• Supplement Date Received by Manufacturer: 01/08/2020
• Initial Report FDA Received Date: 02/03/2020
• Supplement Report FDA Received Date: 03/06/2020
• 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: 78 YR