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

Model Number 72404238

Device Problem Inflation Problem (1310)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/20/2021

Event Type  Injury  

Event Description

It was reported that the patient had a surgical procedure to revise an inflatable penile prosthesis(ipp due to the device not staying erect and inflated after several minutes of sexual activity.All troubleshooting techniques were attempted.No patient complications were reported.

Manufacturer Narrative

The ams700 ipp cylinders were visually inspected and functionally tested; no leaks were found.Both cylinders were pressure tested and performed within specification.The kink resistant tubing (krt) of both cylinders were worn to the filament; however, no leaks were present.The ams 700 momentary squeeze (ms) pump was visually inspected.The pump (krt) was worn to the filament; however, no leaks were present.The pump was functionally tested and failed the 8lb.Activation test.The pump therefore required more than 8lbs.Of force to activate.Product analysis concluded these activation issues could affect the functionality of the pump.Product analysis confirmed pump malfunction.

Event Description

It was reported that the patient had a surgical procedure to revise an inflatable penile prosthesis(ipp) due to the device not staying erect and inflated after several minutes of sexual activity.All troubleshooting techniques were attempted.No patient complications were 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: 11233959
• MDR Text Key: 228833308
• Report Number: 2183959-2021-00154
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953003511
• UDI-Public: 00878953003511
• 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: 03/02/2021

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: 03/03/2021
• Device Model Number: 72404238
• Device Catalogue Number: 72404238
• Device Lot Number: 1000238692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2021
• Initial Date Manufacturer Received: 01/20/2021
• Initial Date FDA Received: 01/26/2021
• Supplement Dates Manufacturer Received: 02/05/2021
• Supplement Dates FDA Received: 03/02/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 42 YR