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

Model Number	72401458
Medical Device Problem Codes	Deflation Problem (1149); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient with an ambicor penile prosthesis (app) presented for a follow up appointment in 2025, where a pumping issue was identified.The left cylinder failed to deflate and remained inflated in the resting position.A revision surgery was scheduled for (b)(6) 2026 to replace the device with a three-piece prosthesis.No patient complications were reported.
Event or Problem Description
It was reported that a patient with an ambicor penile prosthesis (app) presented for a follow up appointment in 2025, where a pumping issue was identified.The left cylinder failed to deflate and remained inflated in the resting position.A revision surgery was scheduled for (b)(6) 2026 to replace the device with a three piece prosthesis.No patient complications were reported.
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Deflation issue, and mechanical issue are acknowledged within the dfu and are not related to off-label use or failure to follow instructions.Additionally, it is concluded that the cause of the allegation cannot be established without product return.The device history record (dhr) confirmed the device to meet specifications prior to shipment therefore concluding manufacturing was not related to the reported event.Based on the information available a conclusion code of unable to exclude device problem was assigned to this investigation.
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.The device history record (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.A risk review was completed 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.Based on the information available, a conclusion code of unable to exclude device problem was assigned to this investigation.
Event or Problem Description
It was reported that a patient with an ambicor penile prosthesis (app) presented for a follow up appointment in 2025, during which a pumping issue was identified.The left cylinder failed to deflate and remained inflated in the resting position.A revision surgery was performed in which the device was replaced with an inflatable penile prosthesis (ipp).No patient complications were reported.

• 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: 23970647
• Report Number: 2124215-2026-00529
• Device Sequence Number: 7845073
• Product Code: FHW
• UDI-Device Identifier: 00878953001029
• UDI-Public: (01)00878953001029(17)200811(10)947074003
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2026
• 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,Followup
• Report Date (Section B): 03/11/2026

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: 08/11/2020
• Device Model Number: 72401458
• Device Catalogue Number: 72401458
• Device Lot Number: 0947074003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2025
• Supplement Date Received by Manufacturer: 01/08/2026; 02/11/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 02/03/2026; 03/11/2026
• Date Device Manufactured: 08/11/2015
• 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: Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male