MAUDE Adverse Event Report: COLOPLAST A/S (2BO)ALPHA I 16CM SCROTAL; INFLATABLE PENILE PROSTHESIS

Model Number 5187301000

Device Problem Device Inoperable (1663)

Patient Problem No Information (3190)

Event Date 05/09/2018

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, the pump does not inflate the cylinders.The reservoir is not visible with ultrasound so must be empty.During the explantation, the reservoir removal was difficult (120 minutes).After 21 years the pump did not circulate the fluid and it was air inside the pump.The reservoir tube was damaged during explant.

Manufacturer Narrative

A titan pump, two cylinders and a reservoir were received for evaluation.Examination and testing of the returned components revealed the detachment sites of the shorter exhaust tube of the pump and the exhaust tube of cylinder 2 appeared rough and irregular, indicating sufficient stress(s) was exerted to separate the site.Separations were noted in the inlet tube of the reservoir.Testing revealed these to be sites of leakage.The separations appear to be within a group of striations, indicating contact with unshod instrumentation.Partial separations within abrasion were noted in the serialized exhaust tube of the pump, the exhaust tubes of cylinders 1 and 2, and in the inlet tube of the pump.Testing revealed these not to be sites of leakage.No functional abnormalities were noted with the pump, cylinders 1 and 2, or the reservoir bladder or lockout valve.Based on previous quality simulations and examination of the returned product, quality concluded that the rough and irregular surfaces associated with these detachment sites indicate that sufficient stress(s) may have been exerted on the non-serialized exhaust tube of the pump and the exhaust tube of cylinder 2 to separate the site while in-vivo.A separation of this type could then allow the loss of fluid, making the device inoperable.The device components were received detached.Examination of the surfaces of the distal end of the reservoir inlet tube revealed markings indicating contact with sharp instrumentation across the entire cross sectional surface.Because these components were released according to manufacturing and quality control procedures, and based on the information received, quality concluded that the damage most likely occurred during or subsequent to explant.This damage is not associated with the cause for failure.Quality reviewed the manufacturing records for this device and confirmed that there were no discrepancies that would have contributed to this complaint and verified that the devices from this lot met all specifications prior to release.Review of nonconforming reports revealed no nonconformance with this lot that would have contributed to the event.A review of the complaint database revealed no significant trends in complaints of this type for lot 0911755.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: (2BO)ALPHA I 16CM SCROTAL
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 7653789
• MDR Text Key: 112840361
• Report Number: 2125050-2018-00487
• 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: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 08/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 5187301000
• Device Catalogue Number: 5187301000
• Device Lot Number: 0911755
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR