MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS Ambicor; device impotence mechanical/hydraulic

Model Number	72401454
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	08/19/2026
Type of Reportable Event	Serious Injury

• 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: 50952826
• Report Number: 2124215-2026-52127
• Device Sequence Number: 18753552
• Product Code: FHW
• UDI-Device Identifier: 00878953000985
• UDI-Public: (01)00878953000985(17)210504(10)134217005
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: 05/04/2021
• Device Model Number: 72401454
• Device Catalogue Number: 72401454
• Device Lot Number: 0134217005
• 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: 09/03/2026
• Initial Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 05/04/2016
• 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: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male