MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 700 CXR; PROSTHESIS, PENIS, INFLATABLE

Model Number	72404013
Medical Device Problem Codes	Nonstandard Device (1420); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
This product was returned to the manufacturer without any report of performance issues or adverse patient effects.The returned device was analyzed and a product deficiency was identified.See additional manufacturer narrative for full investigation details.
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) number and other product specific information.If additional details become available, a supplemental report will be submitted.Upon receipt at the quality assurance laboratory, the returned components underwent a comprehensive evaluation.Microscopic inspection revealed the first cylinder had a hole at the corner of a fold in the middle section.The outer sleeve was completely torn, and broken fabric threads were observed from the proximal end to the distal end.Multiple folds showed wear, and a leak was noted at the same fold corner.The second cylinder exhibited a completely torn outer sleeve with broken fabric threads from the proximal to distal end, wear at multiple folds, and a bulge in the middle when inflated with a syringe.Visual inspection of both rtes showed surface scaling.Microscopic inspection indicated the standard inflate/deflate pump had kink resistant tubing (krt) worn to the filament, and the outer layer of the pump bulb showed wear from contact with the pump strain relief krt junction.The krts were worn to the filament, and the pump exhibited scaling on the bulb.The standard inflate/deflate pump passed the leakage test.Based on the information available and analysis results, the first cylinder leak at the corner of a fold and torn fabric threads and second cylinder bulge and torn fabric threads from wear could have caused or contributed to the device being removed; therefore, a conclusion code of caused traced to component failure was assigned to this investigation.

• Brand Name: AMS 700 CXR
• Common Device Name: PROSTHESIS, PENIS, INFLATABLE
• 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: 23912600
• Report Number: 2124215-2025-93493
• Device Sequence Number: 21338153
• Product Code: JCW
• UDI-Device Identifier: 00878953002705
• UDI-Public: (01)00878953002705
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/29/2025

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: 72404013
• Device Catalogue Number: 72404013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown