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

Model Number	72404233
Medical Device Problem Codes	Nonstandard Device (1420); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2026
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.
Event or Problem Description
It was reported that the cylinder of this inflatable penile prosthesis (ipp) was ruptured.As a result, the cylinders and pump were explanted and replaced.No additional information reported.
Event or Problem Description
It was reported that the cylinder of this inflatable penile prosthesis (ipp) was ruptured.As a result, the cylinders and pump were explanted and replaced.No additional information reported.
Event or Problem Description
It was reported that the cylinder of this inflatable penile prosthesis (ipp) was ruptured.As a result, the cylinders and pump were explanted and replaced.No additional information reported.
Additional Manufacturer Narrative
Correction to field b1: adverse event/product problem.Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a thorough analysis.The pump was microscopically inspected, functionally and leak tested.Under microscope observation, contamination (bodily fluid) was found within the ms pump.As a result, the functional test was not performed.No leaks were identified.The cylinders were microscopically inspected, and leak tested.The microscope test found that the first cylinder had a had broken fabric threads from wear in the proximal end to the middle of the cylinder.The second cylinder had wear at fold in the proximal end of the cylinder.Both cylinders had a hole in the outer tube and broken fabric threads from kink resistant tubing (krt) wear in the proximal end of the cylinder and the krt was worn to the filament.Both cylinders did not pass 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 available information and analysis results, the leaks in both cylinders from krt, supports the reported clinical observation of cylinder hole/perforation.Therefore, a conclusion code of cause traced to component failure was assigned to this investigation.

• Brand Name: AMS 700 CX MS PUMP
• 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: 24217837
• Report Number: 2124215-2026-05396
• Device Sequence Number: 20882113
• Product Code: JCW
• Combination Product (Y/N): Y
• Initial Reporter Country: IT
• 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,Followup,Followup
• Report Date (Section B): 06/18/2026

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: 01/05/2018
• Device Model Number: 72404233
• Device Catalogue Number: 72404233
• Device Lot Number: 114758005
• 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: 01/14/2026
• Supplement Date Received by Manufacturer: 04/10/2026; 05/22/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 04/29/2026; 06/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2016
• 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 Sex: Unknown