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

Model Number	72404233
Medical Device Problem Codes	Inflation Problem (1310); Mechanical Problem (1384); Nonstandard Device (1420); Material Puncture/Hole (1504); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4.Concomitant product udi for reservoir is (b)(4).The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device allegation of migration is a known risk associated with this device type and indicated as such in the instructions for use.
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) was unable to pump the device, and the cylinders were not filling properly.Upon inspection, a tear was identified in the proximal end of the left cylinder.The physician was unsure if the perforation was present before the surgery or if it occurred while attempting to remove it.Additionally, the outer silicone layer of the left cylinder was found to be detached and had migrated toward the distal end.As a result, the device was explanted and replaced.No patient complications were reported.
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) was unable to pump the device, and the cylinders were not filling properly.Upon inspection, a tear was identified in the proximal end of the left cylinder.The physician was unsure if the perforation was present before the surgery or if it occurred while attempting to remove it.Additionally, the outer silicone layer of the left cylinder was found to be detached and had migrated toward the distal end.As a result, the device was explanted and replaced.No patient complications were reported.
Additional Manufacturer Narrative
Model number/catalog number: 720185-01 serial number: n/a batch/lot number: 148373012 model/catalog description: reservoir unique identifier (udi) #(b)(4).Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a thorough analysis.During microscopic evaluation, contamination consistent with bodily fluid was identified within the ms pump; therefore, functional testing was not performed.No leaks were identified.The cylinders were microscopically inspected and leak tested.Microscopic evaluation identified two holes at the proximal end of the first cylinder, consistent with damage from a sharp instrument.The outer sleeve was detached, and broken fabric threads were observed at the proximal end, consistent with wear.Tissue ingrowth was noted along the entire length of the first cylinder.The second cylinder exhibited wear at folds at both the proximal and distal ends.The first cylinder did not pass leak testing, whereas the second cylinder passed.The reservoir was microscopically inspected and leak tested.Microscopic evaluation 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 migration were defined in the product risk documentation.This event type has been accounted for during analysis to support acceptable risk benefit for the product.The reported device allegation of migration is a known risk associated with implant of these device as indicated in the instructions for use (ifu).Based on the information available and the results of the analysis, damage consistent with a sharp instrument was identified and is considered a secondary failure, so the reported clinical observations of a cylinder inflation issue and hole/perforated could not be confirmed.Also, the pump mechanical issue could not be confirmed as functional testing of the pump could not be performed.Therefore, the conclusion codes of cause not established and known inherent risk of device were 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: 24521924
• Report Number: 2124215-2026-12379
• Device Sequence Number: 9723333
• Product Code: JCW
• UDI-Device Identifier: 00878953003467
• UDI-Public: (01)00878953003467(17)180817(10)147119001
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2026

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: 08/17/2018
• Device Model Number: 72404233
• Device Catalogue Number: 72404233
• Device Lot Number: 0147119001
• 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: 02/05/2026
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 77 YR
• Patient Sex: Male