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

Model Number 72404302

Device Problem Failure to Cycle (1142)

Patient Problem Erosion (1750)

Event Date 09/25/2020

Event Type  Injury  

Event Description

It was reported that the patient is waiting for a revision procedure due to the patient was never able to activate the pump as it was too hard, following several attempts the pump extruded from the scrotum with an inflatable penile prosthesis (ipp).The ipp cylinder, pump, and reservoir was explanted.The patient is recovering and will undergo a re-implant procedure in about 6 months.

Event Description

It was reported that the patient is waiting for a revision procedure due to the patient was never able to activate the pump as it was too hard, following several attempts the pump extruded from the scrotum with an inflatable penile prosthesis (ipp).The ipp cylinder, pump, and reservoir was explanted.The patient is recovering and will undergo a re-implant procedure in about 6 months.

Manufacturer Narrative

The returned device was analyzed and the reported allegations of failure to cycle and erosion was not confirmed.Based on a review of all available information, the cause of the reported event could not be determined.

• 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: 10749677
• MDR Text Key: 213498250
• Report Number: 2183959-2020-05101
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953005737
• UDI-Public: 00878953005737
• 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: 11/24/2020

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 Model Number: 72404302
• Device Catalogue Number: 72404302
• Device Lot Number: 1000347397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2020
• Initial Date Manufacturer Received: 10/01/2020
• Initial Date FDA Received: 10/28/2020
• Supplement Dates Manufacturer Received: 11/12/2020
• Supplement Dates FDA Received: 11/25/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR