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

Model Number 72404156

Device Problems Inadequacy of Device Shape and/or Size (1583); Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 10/16/2023

Event Type  Injury  

Event Description

It was reported that the patient was dissatisfied with the rigidity of his inflatable penile prosthesis as well as shortening of his penile length.On physical examination, he had 1/2-inch short implant at the glans penis with floppy tip and bending of his penis.The patient stated he had difficulty with penetration.The patient underwent surgery and the cylinders and pump were removed.A non-bsc penile prosthesis was implanted.There were no reported patient complications.

Manufacturer Narrative

Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis underwent a thorough analysis.The cylinders were visually and microscopically examined, leak and pressure tested.The first cylinder had wear at fold in the distal and proximal end of the cylinder, holes in the outer tube were identified.The cylinder passed leak and pressure tests.The second cylinder had wear at fold in the distal and proximal end of the cylinder, no leaks were identified.The pump was visually and microscopically examined, leak and functionally tested.The pump did not pass inflation and activation tests.The reservoir was not returned for analysis.Based on analysis results, the identified activation and inflation issues in the pump confirmed the reported device mechanical issues.

Event Description

It was reported that the patient was dissatisfied with the rigidity of his inflatable penile prosthesis as well as shortening of his penile length.On physical examination, he had 1/2-inch short implant at the glans penis with floppy tip and bending of his penis.The patient stated he had difficulty with penetration.The patient underwent surgery and the cylinders and pump were removed.A non-bsc penile prosthesis was implanted.There were no reported patient complications.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
• Type of Device: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18120505
• MDR Text Key: 327938159
• Report Number: 2124215-2023-63533
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953003214
• UDI-Public: 00878953003214
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: N970012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/26/2018
• Device Model Number: 72404156
• Device Catalogue Number: 72404156
• Device Lot Number: 0139459004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PUMP AND CYLINDERS UPN: 72404233 LOT: 165865006; PUMP AND CYLINDERS UPN: 72404233 LOT: 165865006
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male