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

Model Number	72404310
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	09/10/2025
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 crack was identified in the pump connecting tube.The pump was explanted and replaced.There were no patient complications reported.
Additional Manufacturer Narrative
Concomitant product udi for reservoir is (b)(4).Concomitant product udi for pump is (b)(4).
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 crack was identified in the pump connecting tube.The pump was explanted and replaced.There were no patient complications reported.
Additional Manufacturer Narrative
Concomitant product udi for reservoir is (b)(4).Concomitant product udi for pump is (b)(4).Upon receipt at our quality assurance laboratory, the returned pump from this inflatable penile prosthesis (ipp) underwent a thorough analysis.Microscopic examination revealed two perforations in the pumps kink resistant tubings (krt), consistent with wear and fatigue.Leakage testing confirmed fluid loss from both krts, originating from fatigue related damage.Functional testing demonstrated that the pump did not operate as intended, as it did not successfully complete the activation tests.Based on the available test results and investigation, product analysis confirmed that the pump krts were leaking due to wear and fatigue, which supports the reported mechanical issue and hole/perforation.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.Based on the information available, a conclusion code of cause traced to component failure was assigned to this investigation.

• 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: 23346987
• Report Number: 2124215-2025-74481
• Device Sequence Number: 18506940
• Product Code: JCW
• UDI-Device Identifier: 00878953003955
• UDI-Public: (01)00878953003955(17)171211(10)804489003
• 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: 2015
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2026

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: 03/25/2020
• Device Model Number: 72404310
• Device Catalogue Number: 72404310
• Device Lot Number: 928413005
• 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: 09/24/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2015
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LOT:928413005 UPN:72404310. PUMP; LOT:928413005 UPN:72404310. PUMP; LOT:930890010 UPN:72404161. RESERVOIR; LOT:930890010 UPN:72404161. RESERVOIR
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Male