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

Model Number	72404272
Medical Device Problem Codes	Mechanical Problem (1384); Nonstandard Device (1420); Material Puncture/Hole (1504); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) went to the hospital because the product did not work properly.Two weeks later, as a result of the inspection, it was confirmed that the right cylinder had a hole, so all components were removed and replaced.No patient complications reported.
Additional Manufacturer Narrative
D4.Concomitant product udi for pump is (b)(4).And for reservoir is (b)(4).
Additional Manufacturer Narrative
D4.Concomitant product udi for pump is (b)(4) and for reservoir is (b)(4).Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a thorough analysis.The pump was visually inspected, functionally and leak tested.No anomalies were found with the pump.The cylinders were visually inspected, and leak tested.The visual test revealed that the first cylinder had two holes in the outer tube from sharp instrument and broken fabric thread due to fatigue in the proximal end of the cylinder.The visual test found that the second cylinder had a hole in the outer tube from sharp instrument in the proximal end of the cylinder.The first cylinder did not pass the leak test, however, the second one did.The reservoir was visually inspected, and leak tested.The visual test found that the reservoir had wear at a fold in reservoir shell.No leaks were identified.Based on the information available and analysis results, the reported clinical observation of device mechanical issue was not confirmed.
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) went to the hospital because the product did not work properly.Two weeks later, as a result of the inspection, it was confirmed that the right cylinder had a hole, so all components were removed and replaced.No patient complications reported.
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) went to the hospital because the product did not work properly.Two weeks later, as a result of the inspection, it was confirmed that the right cylinder had a hole, so all components were removed and replaced.No patient complications reported.
Additional Manufacturer Narrative
D4.Concomitant product udi for pump is (b)(4) and for reservoir is (b)(4).Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a thorough analysis.The pump was visually inspected, functionally and leak tested.No anomalies were found with the pump.The cylinders were visually inspected, and leak tested.The visual test revealed that the first cylinder had two holes in the outer tube from sharp instrument and broken fabric thread due to fatigue in the proximal end of the cylinder.The visual test found that the second cylinder had a hole in the outer tube from sharp instrument in the proximal end of the cylinder.The first cylinder did not pass the leak test, however, the second one did.The reservoir was visually inspected, and leak tested.The visual test found that the reservoir had wear at a fold in reservoir shell.No leaks were identified.Based on the information available and analysis results, the reported clinical observation of device mechanical issue was not confirmed.

• Brand Name: AMS 700 CX
• 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: 22828902
• Report Number: 2124215-2025-56695
• Device Sequence Number: 4463672
• Product Code: JCW
• UDI-Device Identifier: 00878953003795
• UDI-Public: (01)00878953003795(17)220404(10)170641008
• 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: 2018
• 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,Followup
• Report Date (Section B): 02/23/2026

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: 04/04/2022
• Device Model Number: 72404272
• Device Catalogue Number: 72404272
• Device Lot Number: 0170641008
• 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: 07/24/2025
• Supplement Date Received by Manufacturer: 10/06/2025; 01/29/2026
• Initial Report FDA Received Date: 08/18/2025
• Supplement Report FDA Received Date: 10/31/2025; 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2017
• 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: PUMP.; PUMP.; PUMP.; RESERVOIR.; RESERVOIR.; RESERVOIR.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Male