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

Model Number	72401452
Medical Device Problem Codes	Inflation Problem (1310); Mechanical Problem (1384); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient with an ambicor penile prosthesis (app) presented with a nonfunctioning device.A revision surgery was performed, during which the physician explanted the device and replaced it with an inflatable penile prosthesis (ipp).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.Inflation 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.Based on the information available the cause that contributed to the reported event cannot be established.
Additional Manufacturer Narrative
Upon receipt at the quality assurance laboratory, the returned components underwent a comprehensive laboratory evaluation.The ambicor first cylinder had a perforation at the proximal end consistent with sharp instrument contact, wear at two folds in the proximal end and wear at one-fold in the mid section, and a leak associated with the sharp instrument related damage.The ambicor second cylinder had wear at folds in the proximal end and mid section and passed the leakage test.The ambicor pump passed visual inspection, and no damage or abnormalities were identified.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.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.Based on the information available and analysis results, the reported device inflation and mechanical issues could not be confirmed.The damage identified on first cylinder was the result of sharp instrument damage which probably occurred during the explant surgery, and it will be considered a secondary failure; 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 with a nonfunctioning device.A revision surgery was performed, during which the physician explanted the device and replaced it 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: 23916958
• Report Number: 2124215-2025-93526
• Device Sequence Number: 8955123
• Product Code: FHW
• UDI-Device Identifier: 00878953000961
• UDI-Public: (01)00878953000961(17)170727(10)783800004
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• 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: 07/27/2017
• Device Model Number: 72401452
• Device Catalogue Number: 72401452
• Device Lot Number: 783800004
• 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: 12/04/2025
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2012
• 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: 44 YR
• Patient Sex: Male