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

Model Number	72404013
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	01/09/2026
Type of Reportable Event	Serious Injury
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 tear was identified in the right cylinder.All components were explanted and replaced.There were no patient complications reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, ams 700 underwent a thorough analysis.The cylinders were microscopically inspected and leak tested.The first cylinder was found to have a detached outer sleeve, broken and detached fabric threads consistent with wear, and two holes in the inner tube caused by fatigue.The second cylinder exhibited tears at the fold locations in the proximal, middle, and distal sections of the cylinder.The first cylinder did not pass the leak test, however, the second one did.The pump was microscopically inspected, functionally and leak tested.The pump was microscopically inspected and subjected to functional and leak testing.Microscopic examination revealed that the pump kink resistant tubing (krt) was worn down to the filament.The pump did not pass activation testing but successfully passed leak testing.The reservoir was microscopically inspected and leak tested.Microscopic examination identified wear at a fold in the reservoir shell; however, no leaks were detected.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 available information and analysis results, the leak in the tube of the first cylinder, supports the reported clinical observations of cylinder hole/perforation, and device mechanical issue.Therefore, a conclusion code of cause traced to component failure was assigned to this investigation.This record was identified during a retrospective review of complaint events; an electronic medical device report (emdr) was not previously submitted per applicable reporting criteria.Boston scientific has opened a nonconforming events and prevention investigation ((b)(4)) to determine the potential cause for why an emdr was not previously submitted to the food and drug administration (fda) in accordance with boston scientific's established medical device reporting process and fda adverse event reporting requirements.Information gained through these investigation efforts will be utilized to take action(s), as necessary.Model number/catalog number: 72404310 serial number: n/a batch/lot number: 100258004 model/catalog description: pump ms unique identifier (udi) #: (b)(4) model number/catalog number: 72404161 serial number: n/a batch/lot number: 942347002 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 ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 50885563
• Report Number: 2124215-2026-50935
• Device Sequence Number: 9827136
• Product Code: JCW
• UDI-Device Identifier: 00878953002705
• UDI-Public: (01)00878953002705(17)190724(10)892594005
• 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: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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: 07/24/2019
• Device Model Number: 72404013
• Device Catalogue Number: 72404013
• Device Lot Number: 892594005
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/25/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2014
• 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: Required Intervention; Hospitalization
• Patient Age: 78 YR
• Patient Sex: Male