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

Model Number 72404231

Device Problems Inflation Problem (1310); Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/15/2020

Event Type  Injury  

Event Description

It was reported that the patient underwent an inflatable penile prosthesis (ipp) replacement surgery due to the tubing breaking on the white connector towards pump.The patient used device twice.During the procedure the existing device was removed and a new ipp was implanted.No information was provided about the patient's outcome.It was further reported that the patient experienced inflation issues leading to the procedure.The patient did not experience any adverse events and was said to be healing after the procedure.No more information available at the moment.Should additional information become available, it will be provided.

Manufacturer Narrative

H2, h3, h6, h10 updated.Product investigation completed.The ams700 ipp cylinders were visually inspected and functionally tested.A fluid leak, hole in the outer tube and broken fabric threads were present near the distal end of the cylinder body of one of the cylinders.This damage was concluded to be attributed to sharp instrument damage consistent with explant and is therefore considered a secondary failure.Cylinder 2 had a leak near the distal end of the cylinder body attributed to sharp instrument damage.A leak was also identified near the proximal end of the cylinder body due to wear at the corner of a buckling fold.No connectors returned.Product analysis was unable to confirm the allegation of a tubing break on the white connector as no connectors returned; however, a leak was identified in the cylinder body which is the most probable cause of the inflation issue.The product analysis results and event report provided no objective evidence that would warrant further escalation.

Event Description

It was reported that the patient underwent an inflatable penile prosthesis (ipp) replacement surgery due to the tubing breaking on the white connector towards pump.The patient used device twice.During the procedure the existing device was removed and a new ipp was implanted.No information was provided about the patient's outcome.It was further reported that the patient experienced inflation issues leading to the procedure.The patient did not experience any adverse events and was said to be healing after the procedure.No more information available at the moment.Should additional information become available, it will be provided.

• 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: 9639231
• MDR Text Key: 176768325
• Report Number: 2183959-2020-00302
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953003443
• UDI-Public: 00878953003443
• 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: 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/13/2020
• Device Model Number: 72404231
• Device Catalogue Number: 72404231
• Device Lot Number: 1000119564
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2020
• Date Manufacturer Received: 02/25/2020
• Patient Sequence Number: 1
• Treatment: 72404155/1000064831.; 72404155/1000064831.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR