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

Model Number	72404237
Medical Device Problem Codes	Inflation Problem (1310); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4: detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.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.Incomplete inflation is acknowledged within the dfu and are not related to off label use or failure to follow instructions.The dfu provides guidance and instruction to achieve successful ams 700 implantation and to prevent inflation issues.Based on the information available the cause that contributed to the reported event cannot be established.
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) was not working properly as it presented inflation issues.A surgical procedure was performed during which the device was explanted.There were no patient complications reported.
Additional Manufacturer Narrative
Model number/catalog number: 72404155.Serial number: n/a.Batch/lot number: 1000465775.Model/catalog description: reservoir 65 ml pc/iz.Unique identifier (udi) #:(b)(4).Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a thorough analysis.The microscopic visual inspection of the cylinder revealed that cylinder 1 had wear at a fold in the proximal end and the middle of the cylinder, and two holes in the proximal end of the cylinder from sharp instrument which is standard for the explant process.Cylinder 2 had wear at a fold in the proximal end and the middle of the cylinder.The microscopic visual inspection of the pump revealed that pump kink resistant tubing (krt) was worn to the filament.The microscopic visual inspection of the reservoir revealed that the spherical reservoir had scaling, and krt had a hole from sharp instrument damage at the strain relief adapter junction which is standard for the explant process.The leakage test of the cylinder revealed that cylinder 1 had two leaks from sharp instrument in the proximal end of the cylinder.The pump passed functional testing.Cylinder 2 and the pump passed the leakage test.Inflation issue is acknowledged within the instructions for use (ifu) and is not related to off label use or failure to follow instructions.A risk review confirmed that the event of mechanical malfunction (leaks, incomplete inflation/ deflation, kinking) is defined in the product risk documentation.This event type has been accounted for during analysis to support acceptable risk benefit for the product.The device history record (dhr) confirmed that the device met all material, assembly and performance specifications.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established as the sharp instrument damage was a secondary failure which is standard for the explant process.
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) was not working properly as it presented inflation issues.A surgical procedure was performed during which the entire device was explanted.There were no patient complications reported.
Additional Manufacturer Narrative
Model number/catalog number: 72404155, batch/lot number: 1000465775, model/catalog description: reservoir 65 ml pc/iz, unique identifier (udi) #: (b)(4).At this time, the investigation is in progress.Once the investigation is completed the final report will be submitted.
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) was not working properly as it presented inflation issues.A surgical procedure was performed during which the entire device was explanted.There were no patient complications reported.

• 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 ; 5086521217
• MDR Report Key: 24612473
• Report Number: 2124215-2026-14448
• Device Sequence Number: 10181635
• Product Code: JCW
• UDI-Device Identifier: 00878953003504
• UDI-Public: (01)00878953003504(17)230204(10)1000526378
• Combination Product (Y/N): Y
• Initial Reporter Country: TU
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/11/2026

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: 02/04/2023
• Device Model Number: 72404237
• Device Catalogue Number: 72404237
• Device Lot Number: 1000526378
• 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: 02/16/2026
• Supplement Date Received by Manufacturer: 03/20/2026; 04/20/2026
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 04/15/2026; 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2021
• 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 Sex: Unknown