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

Model Number	72404310
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	04/27/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Model number/catalog number: (b)(6).Serial number: n/a.Batch/lot number: 1100259181.Model/catalog description: cx 18cm snap fit rt.Unique identifier (udi) #: (b)(4).Model number/catalog number: (b)(6).Serial number: n/a.Batch/lot number: 1100304506.Model/catalog description: reservoir 65ml pc.Unique identifier (udi) #: (b)(4).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.Therefore, a conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
It was reported that the patient's inflatable penile prosthesis (ipp) was not functioning properly.A surgical procedure was performed during which a crack was found in the pump connecting tube.The pump was replaced and no patient complications were reported.
Event or Problem Description
It was reported that the patient's inflatable penile prosthesis (ipp) was not functioning properly.A surgical procedure was performed during which a crack was found in the pump connecting tube.The pump was replaced and no patient complications were reported.
Additional Manufacturer Narrative
Model number/catalog number: 72404273.Serial number: n/a.Batch/lot number: 1100259181.Model/catalog description: cx 18cm snap fit rt.Unique identifier (udi) #: (b)(4).Model number/catalog number: 72404161.Serial number: n/a.Batch/lot number: 1100304506.Model/catalog description: reservoir 65ml pc.Unique identifier (udi) #: (b)(4).Upon receipt at our quality assurance laboratory, the returned component underwent a thorough analysis.The pump was inspected microscopically and underwent leak and functional testing.Microscopic examination revealed that the pump tubing had been cut down to the pump block, and the tubing was not returned for further analysis.The pump passed the leak test; however, it did not pass the functional 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 and confirmed that the events of mechanical malfunction (leaks, incomplete inflation/ deflation, kinking) and excess force or friction on silicone leads to stress, strains, holes or tears 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 information available and analysis results, the clinical observation of hole/perforation in the tubing was unable to be confirmed as the tubing was not returned for analysis, however, the pump not passing functional test could have caused or contributed to the reported clinical observation of device mechanical issue.

• Brand Name: AMS 700 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: 25394946
• Report Number: 2124215-2026-29908
• Device Sequence Number: 14803791
• Product Code: JCW
• UDI-Device Identifier: 00878953003801
• UDI-Public: (01)00878953003801(17)280219(10)1100259181
• 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: 2023
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2026

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: 03/26/2026
• Device Model Number: 72404310
• Device Catalogue Number: 72404310
• Device Lot Number: 1100276339
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/16/2026
• 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: 05/11/2026
• Supplement Date Received by Manufacturer: 08/03/2026
• Initial Report FDA Received Date: 06/04/2026
• Supplement Report FDA Received Date: 08/31/2026
• Date Device Manufactured: 03/28/2023
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male