MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 700 CXR; prosthesis, penis, inflatable

Model Number	72404013
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	07/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) presented to the hospital with a non-functional device.Two weeks later, a surgical procedure was performed and upon inspection, there was a hole found in the right cylinder.As a result, the physician removed and replaced the right cylinder and pump.The patient was stable following the procedure, and there was no additional information provided.
Additional Manufacturer Narrative
Model number/catalog number: 72404310 serial number: n/a batch/lot number: 1100882666 model/catalog description: pump ms unique identifier (udi) #: (b)(4) model number/catalog number: 72404161 serial number: n/a batch/lot number: 0172108013 model/catalog description: reservoir 65ml pc unique identifier (udi) #: (b)(4).

• 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 fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; +1(508)652-1217
• MDR Report Key: 50256052
• Report Number: 2124215-2026-43736
• Device Sequence Number: 10672422
• Product Code: JCW
• UDI-Device Identifier: 00878953002705
• UDI-Public: (01)00878953002705(17)220317(10)169860008
• 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: 2017
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/14/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/17/2022
• Device Model Number: 72404013
• Device Catalogue Number: 72404013
• Device Lot Number: 0169860008
• 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: 08/12/2026
• Initial Report FDA Received Date: 08/14/2026
• Date Device Manufactured: 03/17/2017
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male