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

Model Number	72404014
Medical Device Problem Codes	Mechanical Problem (1384); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2025
Type of Reportable Event	Serious Injury
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.Based on the information available the cause that contributed to the reported event cannot be established.D4.Concomitant product udi for pump is (b)(4) and reservoir is (b)(4).
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) went to the hospital because the product was not working properly.Two weeks later upon inspection, it was confirmed that the cylinder had a hole, so all components were removed and replaced.No patient complications reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a thorough analysis.The pump was microscopically inspected, functionally tested, and leak tested.Microscope inspection revealed that the pump kink resistant tubing (krt) were worn to the filament.One krt had a hole from fatigue at the strain relief.Leaks were identified.The pump did not meet activation test requirements.The cylinder was microscopically inspected and leak tested.The cylinder exhibited a hole in the outer tube from krt wear in the proximal end to middle of the cylinder.No leaks were identified.The reservoir was microscopically inspected, and leak tested.The microscope test found that the reservoir had a wear at a fold in reservoir shell.No leaks were identified.Based on the information available and the analysis results, the reported clinical observation of device mechanical issue could not be confirmed; however, the pump not meeting functional test requirements may impact product performance.Additionally, the allegation of cylinder hole/perforation was confirmed due to the presence of a hole in the outer tube resulting from krt wear.D4.Concomitant product udi for pump is (b)(4) and reservoir is (b)(4).
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) went to the hospital because the product was not working properly.Two weeks later upon inspection, it was confirmed that the cylinder had a hole, so all components were removed and replaced.No patient complications reported.

• 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: 23598337
• Report Number: 2124215-2025-82439
• Device Sequence Number: 16047262
• Product Code: JCW
• UDI-Device Identifier: 00878953002712
• UDI-Public: (01)00878953002712(17)240312(10)1000242810
• 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: 2021
• 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): 01/23/2026

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: 03/12/2024
• Device Model Number: 72404014
• Device Catalogue Number: 72404014
• Device Lot Number: 1000242810
• 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: 10/23/2025
• Supplement Date Received by Manufacturer: 01/02/2026
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2019
• 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: LOT: 1000264784 UPN 720182-01 RESERVOIR.; LOT: 1000264784 UPN 720182-01 RESERVOIR.; LOT: 1000457745 UPN 72404310 PUMP.; LOT: 1000457745 UPN 72404310 PUMP.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male