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

Model Number	72404172
Medical Device Problem Codes	Fluid/Blood Leak (1250); Inflation Problem (1310); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced inflation issues with an inflatable penile prosthesis (ipp) leading to a replacement surgery being booked due to fluid loss being suspected.There were no patient complications reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this ams 700 underwent a thorough analysis.The cylinders were visually inspected, leak and pressure tested.Both cylinders presented buckling folds in the proximal end of the cylinder.Additionally, the cylinders had wear at a fold in the middle of the cylinder.Both cylinders passed the leakage and pressure tests.Based on the information available and analysis results, the reported clinical observation of fluid loss could not be confirmed.A conclusion code of no problem detected was assigned to this investigation.
Event or Problem Description
It was reported that the patient experienced inflation issues with an inflatable penile prosthesis (ipp) leading to a replacement surgery.During the procedure, fluid loss was noted; however, its source was not detected.There were no patient complications.
Event or Problem Description
It was reported that the patient experienced inflation issues with an inflatable penile prosthesis (ipp) leading to a replacement surgery.During the procedure, fluid loss was noted; however, its source was not detected.There were no patient complications.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this ams 700 underwent a thorough analysis.The cylinders were visually inspected, leak and pressure tested.Both cylinders presented buckling folds in the proximal end of the cylinder.Additionally, the cylinders had wear at a fold in the middle of the cylinder.Both cylinders passed the leakage and pressure tests.The reservoir was visually and microscopically examined not identifying any abnormalities.Leakage testing was performed, there were no leaks identified on the reservoir.Upon visual inspection of the pump, it was noted that the kink resistant tubing (krt) was worn to the filament; however, the component passed the leak test.Functional testing of the pump revealed that the component did not pass the activation tests 2 and 3.Based on the information available and analysis results, the reported clinical observation of inflation issues was confirmed.A conclusion code of cause traced to component failure was assigned to this investigation.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
• Common Device Name: 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: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 17221380
• Report Number: 2124215-2023-33557
• Device Sequence Number: 20386924
• Product Code: FHW
• UDI-Device Identifier: 00878953003269
• UDI-Public: 00878953003269
• Combination Product (Y/N): Y
• Initial Reporter Country: AS
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/11/2023

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: 09/19/2019
• Device Model Number: 72404172
• Device Catalogue Number: 72404172
• Device Lot Number: 0187806004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2023
• Supplement Date Received by Manufacturer: 08/07/2023; 08/31/2023
• Initial Report FDA Received Date: 06/28/2023
• Supplement Report FDA Received Date: 08/28/2023; 09/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BALLOON: 72404155/1000098137; BALLOON: 72404155/1000098137; BALLOON: 72404155/1000098137; PUMP: 72404209/1000111390; PUMP: 72404209/1000111390; PUMP: 72404209/1000111390
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male