MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS AMBICOR; DEVICE IMPOTENCE MECHANICAL/HYDRAULIC

Model Number	72401454
Medical Device Problem Codes	Deflation Problem (1149); Mechanical Problem (1384); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's ambicor penile prosthesis (app) was not functioning properly as it exhibited deflation issues.Additionally, the pump was rigid and unable to be pumped.A surgical procedure was performed to remove the app, and at a later time, a new inflatable penile prosthesis (ipp) was implanted.No patient complications were reported.
Event or Problem Description
It was reported that the patient's ambicor penile prosthesis (app) was not functioning properly as it exhibited deflation issues.Additionally, the pump was rigid and unable to be pumped.A surgical procedure was performed to remove the app, and at a later time, a new inflatable penile prosthesis (ipp) was implanted.No patient complications were reported.
Additional Manufacturer Narrative
Device technical analysis: upon receipt at our quality assurance laboratory, the returned components underwent a thorough analysis.The first cylinder was visually inspected and leak tested.Visual inspection revealed wear at a fold in the middle and at the proximal end of the cylinder, as well as frayed fabric threads and a bulge in the proximal area.The leakage test revealed that the first cylinder developed a noticeable bulge in the proximal end when inflated with a syringe.The second cylinder was visually inspected and leak tested.Visual inspection revealed wear at a fold in the middle of the cylinder, and a broken rod was identified in the rear tip.The pump was visually inspected and revealed no damage or abnormalities, successfully passing the test.Device history record (dhr): the dhr review confirmed that the device met all material, assembly and performance specifications.A review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.Labeling review: a review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.Risk review: a risk review was completed using d055394 ambicor hazard analysis and confirmed that the event of deflation issue and mechanical issue was defined in the product risk documentation.This event type has been accounted for during analysis to support acceptable risk benefit for the product.Investigation conclusion: based on the information available and the analysis results, the frayed fabric threads and the bulging identified in the first cylinder could have caused or contributed to the reported device deflation issue.A conclusion code of cause traced to component failure was assigned to this investigation.

• Brand Name: AMS AMBICOR
• 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: 24122611
• Report Number: 2124215-2026-03695
• Device Sequence Number: 9371468
• Product Code: FHW
• UDI-Device Identifier: 00878953000985
• UDI-Public: (01)00878953000985(17)210329(10)127556002
• Combination Product (Y/N): N
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2026

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: 03/29/2021
• Device Model Number: 72401454
• Device Catalogue Number: 72401454
• Device Lot Number: 0127556002
• 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: 12/29/2025
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2016
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Male