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

Model Number	720182-01
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	03/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Based on the information available, the cause that contributed to the reported event cannot be established; a conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) was not performing as expected.Two weeks later a revision surgery was performed, upon examination a hole in the reservoir was found.Therefore, it was decided to replace the reservoir and pump, leaving the previous reservoir implanted.No patient complications were reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, it was noted that only the pump component of the inflatable penile prosthesis (ipp) was returned.Visual and microscopic analysis found the pump tubing was cut down to the pump block; no tubing was returned for analysis.Leak testing was performed, and no leaks were identified.Functional testing found the pump did not pass activation testing.Analysis confirmed the presence of a device issue that would have impacted device functionality; however, the presence of a hole in the reservoir could not be confirmed as the component was not returned.Based on the findings of this investigation, a conclusion of cause traced to component failure was assigned to this event.Corrected field d6b explant date - removed date as reservoir remains implanted and out of service.
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) was not performing as expected.Two weeks later a revision surgery was performed, upon examination a hole in the reservoir was found.Therefore, it was decided to replace the reservoir and pump, leaving the previous reservoir implanted.No patient complications were reported.

• 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: 19033726
• Report Number: 2124215-2024-19603
• Device Sequence Number: 20600345
• Product Code: FHW
• UDI-Device Identifier: 00878953005676
• UDI-Public: 00878953005676
• 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: 2017
• 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): 08/05/2024

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: 11/20/2020
• Device Model Number: 720182-01
• Device Catalogue Number: 720182-01
• Device Lot Number: 0111608015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/19/2024
• Supplement Date Received by Manufacturer: 08/02/2024
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: LGX 18CM: UPN: 72404293 / LOT: 0147169005; LGX 18CM: UPN: 72404293 / LOT: 0147169005; PUMP: UPN: 72404310 / LOT: 0157691001; PUMP: UPN: 72404310 / LOT: 0157691001
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male