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

Model Number	72404011
Medical Device Problem Codes	Break (1069); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was seen by the physician as the inflatable penile prosthesis (ipp) did not work as expected.Two weeks later, the ipp was removed and replaced due to a crack in the pump connector.No patient complications were reported.
Event or Problem Description
It was reported that the patient was seen by the physician as the inflatable penile prosthesis (ipp) did not work as expected.Two weeks later, the ipp was removed and replaced due to a crack in the pump connector.No patient complications were reported.
Additional Manufacturer Narrative
Upon receipt of this inflatable penile prosthesis (ipp) at our quality assurance laboratory, the returned components underwent a thorough analysis.The pump was visually and microscopically inspected and leak tested.Contamination was identified within the pump.To avoid damaging the test equipment, the pump was not functionally tested due to this contamination.The reservoir was visually inspected and leak tested.No visual abnormality was found and the reservoir passed leak testing.The cylinders were visually inspected and leak tested.Each cylinder had wear at a fold in the cylinder body but they both passed leak testing.Based on the information available and analysis results, the reported connector break and mechanical issue were unable to be confirmed and the cause was unable to be 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: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 17553087
• Report Number: 2124215-2023-43694
• Device Sequence Number: 19728828
• Product Code: FHW
• UDI-Device Identifier: 00878953002682
• UDI-Public: 00878953002682
• 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: 2018
• 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): 10/20/2023

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: 08/12/2023
• Device Model Number: 72404011
• Device Catalogue Number: 72404011
• Device Lot Number: 1000146565
• 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: Not provided
• Supplement Date Received by Manufacturer: 09/29/2023
• Initial Report FDA Received Date: 08/15/2023
• Supplement Report FDA Received Date: 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2018
• 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 181502008; RESERVOIR UPN 72404161 LOT179203005
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male