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

Model Number	72404012
Medical Device Problem Codes	Mechanical Problem (1384); Nonstandard Device (1420); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The concomitant product of reservoir was manufactured prior to implementation of the udi regulation and as a result, the complete udi is not available.Applicable us product data has been included in this report.
Event or Problem Description
It was reported that the patient visited the hospital because his inflatable penile prosthesis (ipp) was not functioning properly.The patient underwent surgery two weeks later and upon inspection, a hole was identified in the cylinder.Both cylinders and the pump were explanted and replaced.There were no patient complications reported.
Event or Problem Description
It was reported that the patient visited the hospital because his inflatable penile prosthesis (ipp) was not functioning properly.The patient underwent surgery two weeks later and upon inspection, a hole was identified in the cylinder.Both cylinders and the pump were explanted and replaced.There were no patient complications reported.
Additional Manufacturer Narrative
Correction to b1: adverse event/product problem.Model number/catalog number: 72400152.Serial number: n/a.Batch/lot number: 789019008.Model/catalog description: reservoir 65ml.Unique identifier (udi) # the concomitant product of reservoir was manufactured prior to implementation of the udi regulation and as a result, the complete udi is not available.Applicable us product data has been included in this report.Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a thorough analysis.The cylinders were microscopically inspected and leak tested.The microscope inspection for the first cylinder identified a hole at a corner of a fold in the distal end of the cylinder.There was wear at fold in the proximal end, middle, and distal end of the cylinder.The leakage test revealed that the first cylinder had a leak at corner of a fold in the distal end of the cylinder.The microscope inspection for the second cylinder identified broken fabric threads and torn outer sleeve from wear in the proximal end of the cylinder.The leakage test revealed that the second cylinder had a bulge in the proximal end of the cylinder when inflated with syringe.The pump was microscopically inspected and leak tested.Microscopic inspection revealed that the pump had kink-resistant tubing (krt) worn to filament; outer layer of pump bulb worn from wear against the pump strain relief krt junction.The pump passed the leak test.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 events of mechanical malfunction (leaks, incomplete inflation/ deflation, kinking) and device has a fluid leak were 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 and analysis results, the leak at the corner of a fold in the first cylinder, the bulging in the second cylinder and the pump krt worn to filament could have caused or contributed to the reported clinical observation of a hole/perforation and mechanical issue, a conclusion code of cause 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: 23691961
• Report Number: 2124215-2025-87211
• Device Sequence Number: 9193576
• Product Code: JCW
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2026

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: 04/16/2017
• Device Model Number: 72404012
• Device Catalogue Number: 72404012
• Device Lot Number: 768779003
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2012
• 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
• Concomitant Medical Products and Therapy/Usage Dates: RESERVOIR: UPN: 72400152 / LOT: 789019008
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male