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

Model Number	72404301
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this inflatable penile prosthesis was removed as it would not inflate as expected.A new inflatable penile prosthesis was implanted.No patient complications were reported.
Event or Problem Description
It was reported that this inflatable penile prosthesis was removed as it would not inflate as expected.A new inflatable penile prosthesis was implanted.No patient complications were reported.
Additional Manufacturer Narrative
Upon receipt of this inflatable penile prosthesis pump and cylinders at our quality assurance laboratory, the returned components underwent a thorough analysis.Both cylinders were visually inspected, and leak tested.The first cylinder had a hole with fluid loss from a sharp instrument in the proximal end of the cylinder.The second cylinder passed visual inspection and the leakage test.There were no visual damages or abnormalities found.The pump was visually inspected, leak tested, and functionally tested.- the pump passed visual inspection and there were no visual damages or abnormalities found.The pump passed the leak test and functional testing.Based on the information available and analysis results, the reported deflation issue was unable to be confirmed and the cause was not established.

• 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: 18193841
• Report Number: 2124215-2023-66094
• Device Sequence Number: 15382453
• Product Code: FHW
• UDI-Device Identifier: 00878953005720
• UDI-Public: 00878953005720
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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
• Report Date (Section B): 01/10/2024

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 Model Number: 72404301
• Device Catalogue Number: 72404301
• Device Lot Number: 1100160718
• 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: 11/03/2023
• Supplement Date Received by Manufacturer: 12/19/2023
• Initial Report FDA Received Date: 11/22/2023
• Supplement Report FDA Received Date: 01/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2022
• 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: RESERVOIR UPN 720182-01 LOT 1100328068; RESERVOIR UPN 720182-01 LOT 1100328068
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 37 YR
• Patient Sex: Male