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

Model Number	72401450
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this ambicor penile prosthesis (app) was too short, and the physician attempted to reposition it during revision surgery.During the repositioning, the device was damaged with an instrument and subsequently explanted.A new inflatable penile prosthesis (ipp) was implanted.There were no patient complications reported.
Additional Manufacturer Narrative
There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The device performance allegation cannot be confirmed.Based on the information available, a conclusion code of unintended use error caused or contributed to event was assigned to this investigation.
Event or Problem Description
It was reported that this ambicor penile prosthesis (app) was too short, and the physician attempted to reposition it during revision surgery.During the repositioning, the device was damaged with an instrument and subsequently explanted.A new inflatable penile prosthesis (ipp) was implanted.There were no patient complications 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: 22202511
• Report Number: 2124215-2025-37876
• Device Sequence Number: 6765078
• Product Code: FHW
• UDI-Device Identifier: 00878953000947
• UDI-Public: (01)00878953000947
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• 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): 07/21/2025

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 Model Number: 72401450
• Device Catalogue Number: 72401450
• 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: 05/20/2025
• Supplement Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 07/21/2025
• 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 Sex: Unknown