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

Model Number 72404310

Device Problem Collapse (1099)

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

Event Date 11/01/2019

Event Type  Injury  

Event Description

It was reported that the patient experienced dimpled pump with an inflatable penile prosthesis (ipp).The ipp pump was explanted and a new ipp pump was implanted.Additional information was reported that the pump remained flat after being pressed.

Manufacturer Narrative

Device analysis: product analysis was unable to confirm the reported events.Product analysis could not confirm the reported events.The product record review indicated that the reported events do not represent an unanticipated event.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 of the pump.Based on the results of this investigation, no escalation is required.

Event Description

It was reported that the patient experienced dimpled pump with an inflatable penile prosthesis (ipp).The ipp pump was explanted and a new ipp pump was implanted.Additional information was reported that the pump remained flat after being pressed.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS
• Type of Device: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 9395926
• MDR Text Key: 168644168
• Report Number: 2183959-2019-67821
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953003986
• UDI-Public: 00878953003986
• Combination Product (y/n): N
• PMA/PMN Number: N970012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/26/2021
• Device Model Number: 72404310
• Device Catalogue Number: 72404310
• Device Lot Number: 0151180005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Initial Date Manufacturer Received: 11/07/2019
• Initial Date FDA Received: 12/02/2019
• Supplement Dates Manufacturer Received: 12/17/2019
• Supplement Dates FDA Received: 01/14/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR