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

Model Number	72404011
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Defective Device (2588)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2022
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 the patient underwent surgical intervention to explant the inflatable penile prosthesis (ipp) due to it the device not fully extending into the glans.A new ipp was implanted.There were no patient complications reported.
Event or Problem Description
It was reported that the patient underwent surgical intervention to explant the inflatable penile prosthesis (ipp) due to it the device not being long enough for the patient.During the original implant, the physician found that the patient had fibrosis and required dilation to implant the ipp.Later, the patient experienced issues with the device not being long enough to extend into the glans resulting in difficulty with sexual intercourse.New longer cylinders were implanted, and there were no patient complications reported.
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.Updated information for b5 describe event, b7 other relevant history, and h6 patient code, h6 device code.
Event or Problem Description
It was reported that the patient underwent surgical intervention to explant the inflatable penile prosthesis (ipp) due to it the device not being long enough for the patient.During the original implant, the physician found that the patient had fibrosis and required dilation to implant the ipp.Later, the patient experienced issues with the device not being long enough to extend into the glans resulting in difficulty with sexual intercourse.New longer cylinders were implanted, and there were no patient complications reported.
Additional Manufacturer Narrative
Upon receipt of the inflatable penile prosthesis (ipp) at our quality assurance laboratory, the returned components underwent a thorough analysis.The cylinders were examined, and there was no evidence of abnormalities or leaks present.Based on the information available, the analysis could not confirm the reported allegations, and there was no problem detected.

• 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: 16539944
• Report Number: 2124215-2023-11587
• Device Sequence Number: 20664076
• Product Code: FHW
• UDI-Device Identifier: 00878953002682
• UDI-Public: 00878953002682
• 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: 2022
• 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): 05/08/2023

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: 06/21/2026
• Device Model Number: 72404011
• Device Catalogue Number: 72404011
• Device Lot Number: 1000584993
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/01/2023
• Supplement Date Received by Manufacturer: 03/15/2023; 05/05/2023
• Initial Report FDA Received Date: 03/14/2023
• Supplement Report FDA Received Date: 03/17/2023; 05/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2021
• 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#: 1100118722.; PUMP: UPN: 72404310 LOT#: 1100118722.; PUMP: UPN: 72404310 LOT#: 1100118722.; RESERVOIR: LOT#: 720182-01 LOT#: 1000527861.; RESERVOIR: LOT#: 720182-01 LOT#: 1000527861.; RESERVOIR: UPN: 720182-01 LOT#: 1000527861.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 43 YR
• Patient Sex: Male
• Patient Weight: 65 KG