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

Model Number	72404293
Medical Device Problem Codes	Mechanical Problem (1384); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient went to the clinic because this inflatable penile prosthesis (ipp) was not working properly.Two weeks later, a surgical procedure was performed, during which a crack in the cylinder connecting tube was identified.The cause of the hole was not detailed by the hospital.All the components were removed and replaced.There were no patient complications reported.
Event or Problem Description
It was reported that the patient went to the clinic because this inflatable penile prosthesis (ipp) was not working properly.Two weeks later, a surgical procedure was performed, during which a crack in the cylinder connecting tube was identified.The cause of the hole was not detailed by the hospital.All the components were removed and replaced.There were no patient complications reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a thorough analysis.The cylinders were microscopically inspected, and leak tested].Microscope inspection of the cylinders revealed that both cylinders had holes in the outer tube from kink resistant tubing (krt) wear in the proximal end of the cylinder.Both cylinders had wear at fold in the proximal end, middle, and distal end of the cylinder.Both cylinders passed the leakage test.The pump was microscopically inspected and the krt was found to be worn to the filament.The pump did pass the leak test and functional testing.Investigation of the reservoir found wear at a fold in the reservoir shell.The leak test revealed the strain relief krt junction leaked but was consistent with sharp instrument damage.Based on the information available and analysis results, the holes found in the outer tube of both cylinders from krt wear could have caused or contributed to the reported allegation of hole/perforation; therefore, a conclusion code of cause traced to component failure was assigned to this investigation.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS
• 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 20558757
• Report Number: 2124215-2024-66562
• Device Sequence Number: 3250960
• Product Code: FHW
• UDI-Device Identifier: 00878953003955
• UDI-Public: 00878953003955
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• 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
• Report Date (Section B): 12/13/2024

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: 02/13/2024
• Device Model Number: 72404293
• Device Catalogue Number: 72404293
• Device Lot Number: 1000230253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2024
• Supplement Date Received by Manufacturer: 11/19/2024
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2019
• 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: PUMP: UPN: 72404310 / LOT: 1000435422; PUMP: UPN: 72404310 / LOT: 1000435422; RESERVOIR: UPN: 72404161 / LOT: 1000310859; RESERVOIR: UPN: 72404161 / LOT: 1000310859
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male