MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE; DEVICE IMPOTENCE MECHANICAL/HYDRAULIC

Model Number 72404232-10

Device Problems Inflation Problem (1310); Device Contamination with Chemical or Other Material (2944)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/29/2020

Event Type  malfunction  

Event Description

It was reported that during an implant procedure, it was noticed that the inflatable penile prosthesis (ipp) cylinders would not inflate.The cylinder in the right side of the patient appeared to be less inflating than the other side, which was never seen before.It is suspected that there was a piece of debris or particle wedged inside the implant.Multiple cycles were attempted, but the physician did not feel good about implanting the device.Procedure was completed with another of the same device.No patient complications.

Manufacturer Narrative

Investigation summary: with all the available information, boston scientific concludes that the visual inspection of the device did not identify any leaks in the device or any presence of foreign material.The device was functionally tested and all components performed within specification.Based on the testing results, the reported allegations of foreign material and inflation issues were unable to be confirmed.Device history review (dhr).The device history record (dhr) confirmed that the devices met all material, assembly and performance specifications.Device analysis: visual inspection of the device did not identify any leaks.The device was functionally tested and all components performed within specifications.Investigation conclusion: based on this investigation, the investigation conclusion code of no problem detected was chosen because the reported events could not be confirmed or substantiated through investigation.Based on the results of this investigation, no escalation is required.

Event Description

It was reported that during an implant procedure, it was noticed that the inflatable penile prosthesis (ipp) cylinders would not inflate.The cylinder in the right side of the patient appeared to be less inflating than the other side, which was never seen before.It is suspected that there was a piece of debris or particle wedged inside the implant.Multiple cycles were attempted, but the physician did not feel good about implanting the device.Procedure was completed with another of the same device.No patient complications.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
• Type of Device: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 11231357
• MDR Text Key: 228833039
• Report Number: 2183959-2021-00147
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953009780
• UDI-Public: 00878953009780
• Combination Product (y/n): N
• PMA/PMN Number: N970012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/21/2022
• Device Model Number: 72404232-10
• Device Catalogue Number: 72404232-10
• Device Lot Number: 1000476333
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Date Manufacturer Received: 02/15/2021
• Patient Sequence Number: 1
• Patient Age: 69 YR