MAUDE Adverse Event Report: COLOPLAST A/S ALPHA I 18CM SCROTAL; INFLATABLE PENILE PROSTHESIS

Model Number	5187401000
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Information (3190)
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, the device, which had been implanted ten years ago, was unable to be cycled to inflate it.It was reported that the event was observed two months ago.The device was explanted and replaced with another device.
Additional Manufacturer Narrative
This follow-up mdr is created to document the corrected device information and evaluation of the returned device.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.A alpha i pump, two cylinders and reservoir were received for evaluation.Examination and testing of the returned components revealed separations within abrasion on the exhaust tubes of both pumps.Testing revealed these to be sites of leakage.A separation with abrasion adjacent to it was noted on the inlet tube of the reservoir.Testing revealed this to be a site of leakage.Two separations were noted in the reservoir bladder due to material degradation.Testing revealed these to be sites of leakage.Groups of partial separations, indicating contact with unshod instrumentation, were noted on the exhaust tube of cylinder 2 and reservoir strain relief.Testing revealed these to not be sites of leakage.A partial separation was also noted on the inlet tube of the reservoir.Testing revealed this to not be a site of leakage.No functional abnormalities were noted with the pump.Based on examination of the returned product, it was concluded that the abrasion marks noted on both cylinder exhaust tubes matched in such a way to conclude that they had overlapped and abraded against one another while in-vivo.The inlet tube of the reservoir was kinked onto itself for a period of time while in-vivo.These positionings, in combination with device usage over time, could contribute to sufficient stress to cause several separations throughout the two exhaust tubes and reservoir inlet tube.Separations of this type would then allow the loss of fluid, making the device inoperable.In addition, the human body is capable of causing thermal and biological degradation, oxidation, and hydrolysis to occur in polyurethane.Although usually this degradation exists as surface phenomenon, over time it may cause mechanical failure.Polymers under constant flexing are more susceptible to fatigue and eventual mechanical failure.The device was assumed functional for over 10 years in the patient.Material degradation occurred and progressed enough to cause two separations in the reservoir bladder.Occurrences of this nature are estimated to be relatively rare.Separations of this type would also allow the loss of fluid, making the device inoperable.

• Brand Name: ALPHA I 18CM SCROTAL
• Common Device Name: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 9497723
• Report Number: 2125050-2019-01156
• Device Sequence Number: 11262970
• Product Code: FHW
• UDI-Device Identifier: 05708932487306
• UDI-Public: 05708932487306
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2020

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: 5187401000
• Device Catalogue Number: 518740
• Device Lot Number: 199568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2019
• Initial Date Received by Manufacturer: 11/20/2019
• Supplement Date Received by Manufacturer: 11/20/2019
• Initial Report FDA Received Date: 12/19/2019
• Supplement Report FDA Received Date: 02/27/2020
• 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: 68 YR