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

Model Number 72404236

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/10/2020

Event Type  Injury  

Event Description

It was reported that the patient underwent an inflatable penile prosthesis (ipp) surgery due to cylinder broke.All system was explanted and a new ipp was implanted.No patient complication was reported.

Manufacturer Narrative

The complaint component was returned and analyzed, and the reported allegation was confirmed via product analysis.One of the cylinders exhibited a bulge when inflated while the other cylinder had a hole in the inner tube attributed to fatigue.Product analysis therefore cylinder damage as the probable cause of the event, as the identified damage could lead to cylinder malfunction.The event cannot be reproduced or substantiated; therefore, no escalation to ncep, capa or scar is required.

Event Description

It was reported that the patient underwent an inflatable penile prosthesis (ipp) surgery due to cylinder broke.All system was explanted and a new ipp was implanted.No patient complication was reported.

• 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: 9634948
• MDR Text Key: 176552602
• Report Number: 2183959-2020-00274
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953003498
• UDI-Public: 00878953003498
• 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: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/09/2012
• Device Model Number: 72404236
• Device Catalogue Number: 72404236
• Device Lot Number: 647050002
• 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: 72404155/645408000.; 72404155/645408000.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR