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

Model Number	72404234
Medical Device Problem Codes	Fluid/Blood Leak (1250); Inflation Problem (1310); Mechanical Problem (1384); Material Puncture/Hole (1504); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation summary: product analysis of the returned device was unable to confirm the reported event related to cylinder has fluid leak but confirmed a pump malfunction.Dhr review: the device history record (dhr) confirmed that the device met all material, assembly and performance specifications.Technical analysis: upon return the device was thoroughly inspected.Visual analysis of the cylinders found a leak in cylinder 1 at the rear tip at the bonding fabric junction.Based on the microscopic inspection of the edges of this hole, it was concluded to be attributed to sharp instrument damage.The cylinder was not pressure tested due to this leak.Cylinder 2 performed within specification.The pump was visually inspected and revealed that the kink resistant tubing (krt) was worn to the filament; however, no leaks were present.The pump was functionally tested and failed the 8lb activation test; therefore required more than 8lbs of force to activate.Labeling review: a review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.Investigation conclusion: based on the information available, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that the patient experienced mechanical issues with an inflatable penile prosthesis (ipp) after hearing a "pop" during its use.Troubleshooting steps were taken to try to inflate the device to no avail.A surgical procedure was performed in which the existing cylinders were removed and replaced with new components.During the procedure, fluid loss was noted at the base of the cylinders due to a hole.The patient did not experience any complications.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
• Common Device Name: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 11541871
• Report Number: 2183959-2021-01009
• Device Sequence Number: 3815253
• Product Code: FHW
• UDI-Device Identifier: 00878953003474
• UDI-Public: 00878953003474
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/22/2021

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/20/2019
• Device Model Number: 72404234
• Device Catalogue Number: 72404234
• Device Lot Number: 0169014002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 03/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 64 YR