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

Model Number 72404257

Device Problem Failure to Cycle (1142)

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

Event Date 12/19/2019

Event Type  malfunction  

Event Description

It was reported that during an inflatable penile prosthesis (ipp) procedure, it was found that the pump was not cycling correctly and was removed immediately during surgery and replaced with another pump.

Event Description

It was reported that during an inflatable penile prosthesis (ipp) procedure, it was found that the pump was not cycling correctly and was removed immediately during surgery and replaced with another pump.

Manufacturer Narrative

The complaint component was returned and analyzed, and the reported allegation was not confirmed via product analysis.Product analysis could not confirm the reported events as device analysis concluded the pump performed within specification.The product record review indicated that the reported events do not represent an unanticipated event.Review of the manufacturing documentation confirmed all required in-process and final inspections and testing were completed.The event cannot be reproduced or substantiated; therefore, no escalation to ncep, capa or scar is required.

• 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: 9583454
• MDR Text Key: 175419132
• Report Number: 2183959-2020-00059
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953003658
• UDI-Public: 00878953003658
• 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: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/13/2021
• Device Model Number: 72404257
• Device Catalogue Number: 72404257
• Device Lot Number: 1000317147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Date Manufacturer Received: 01/31/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR