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

Model Number 5187401000

Device Problems Crack (1135); Inflation Problem (1310); Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 07/31/2019

Event Type  Injury  

Manufacturer Narrative

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 Description

According to the available information, system wouldn't inflate - device was out of fluid.

Manufacturer Narrative

This follow-up mdr is created to document the conclusion of the evaluation and updated lot number.An alpha i pump and two cylinders were received for evaluation.Examination and testing of the returned components revealed an aneurysm in the bladder of cylinder 2.Testing revealed this to be a site of leakage.Surface crazing was noted on the bladder of cylinder 2.A partial separation, with abrasion adjacent to it, was noted in the serialized strain relief of the pump.Testing revealed this to not be a site of leakage.Abrasion was noted on both cylinder exhaust tubes.No functional abnormalities were noted with the pump or cylinder 1.Based on examination, it was concluded that while in-vivo enough pressure may have been exerted to result in an aneurysm on the bladder of cylinder 2.It was further concluded that this pressure, in combination with device usage, could contribute to sufficient stress (s) to separate the bladder at this site.Surface crazing was noted around the aneurysm site.A separation of this type 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.

Manufacturer Narrative

This follow-up mdr is created to document the additional patient weight, medical history, and event information.

Event Description

Additional information indicated the patient reported inability to inflate the device x4-5 months.The patient denies associated pain or voiding difficulty.Additional information also indicated crack in tubing.The reservoir remained implanted.The pump and cylinders were explanted.

• Brand Name: ALPHA I 18CM SCROTAL
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 9045549
• MDR Text Key: 160178204
• Report Number: 2125050-2019-00749
• Device Sequence Number: 1
• Product Code: FHW
• 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,Followup
• Report Date: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 5187401000
• Device Catalogue Number: 518740
• Device Lot Number: 766954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2019
• Date Manufacturer Received: 08/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Weight: 110