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

Model Number	72404012
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	11/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant product udi for pump is (b)(4).Concomitant product udi for reservoir is (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.
Event or Problem Description
It was reported that the patient's inflatable penile prosthesis (ipp) was not working properly.During a surgical procedure, a hole was identified in the left cylinder.Both cylinders and the pump were replaced.The patient's condition following the procedure is stable.No additional information was provided.
Additional Manufacturer Narrative
Model number/catalog number: 72404310.Serial number: n/a.Batch/lot number: 0162998005.Model/catalog description: pump ms.Unique identifier (udi) #: (b)(4).Model number/catalog number: 72404161.Serial number: n/a.Batch/lot number: 0168157014.Model/catalog description: reservoir 65ml pc.Unique identifier (udi) #: (b)(4).Upon receipt at our quality assurance laboratory, the returned components underwent a thorough analysis.The first cylinder was subjected to microscopic inspection and leak testing.The microscopic assessment showed broken fabric threads due to fatigue at the proximal end of the cylinder.Additionally, first cylinder exhibited wear at the fold located in both the proximal end and the middle portion of the cylinder.During the leak test, the first cylinder demonstrated a bulge in the proximal end when inflated with a syringe.The second cylinder also underwent microscopic inspection and leak testing.The microscopic evaluation revealed wear at the fold in the proximal end and in the middle of the cylinder.The second cylinder passed the leak test.The pump was inspected microscopically, leak tested and functionally tested.The microscopic inspection identified scaling on the ms pump block, as well as wear and scaling on the ms pump krt.The pump passed the leak test.However, the functional test showed that the ms pump did not pass activation tests 2 and 3.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 cylinder aneurysm/bulge" 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 cylinder hole/perforated was unable to be confirmed through product analysis; however, the bulge identified in the first cylinder could have caused or contributed to the reported clinical observation of device mechanical issue.Additionally, the pump not passing the functional test could affect product performance.Therefore, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that the patient's inflatable penile prosthesis (ipp) was not working properly.During a surgical procedure, a hole was identified in the left cylinder.Both cylinders and the pump were replaced.The patient's condition following the procedure is stable.No additional information was provided.

• Brand Name: AMS 700 CXR
• 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: 23928211
• Report Number: 2124215-2025-93829
• Device Sequence Number: 8825365
• Product Code: JCW
• UDI-Device Identifier: 00878953002699
• UDI-Public: (01)00878953002699(17)211129(10)157553005
• 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: 2017
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2026

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: 11/29/2021
• Device Model Number: 72404012
• Device Catalogue Number: 72404012
• Device Lot Number: 0157553005
• 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: 12/08/2025
• Supplement Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2016
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PUMP: UPN: 72404310 / LOT: 0162998005; RESERVOIR: UPN: 72404161 / LOT: 0168157014
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Male