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

Model Number	72404013
Medical Device Problem Codes	Fluid/Blood Leak (1250); Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that while repeatedly pressing the control switch on the pump of the inflatable penile prosthesis (ipp) it would rebound normally but the cylinder had no response and would not inflate normally.A surgical procedure was performed during which the device was explanted and replaced.Upon explant the physician noticed water was reduced in the reservoir.The patient was stable following the procedure, and there were no patient complications reported.
Additional Manufacturer Narrative
Model number/catalog number: 720182-01.Serial number: n/a.Batch/lot number: 0178273001.Model/catalog description: reservoir flat 100 ml.Unique identifier (udi) #: (b)(4).Model number/catalog number: 72404310.Serial number: n/a.Batch/lot number: 0176309003.Model/catalog description: pump ms.Unique identifier (udi) #: (b)(4).
Event or Problem Description
It was reported that while repeatedly pressing the control switch on the pump of the inflatable penile prosthesis (ipp) it would rebound normally but the cylinder had no response and would not inflate normally.A surgical procedure was performed during which the device was explanted and replaced.Upon explant the physician noticed water was reduced in the reservoir, considered to be natural loss as there was no leaking observed.The patient was stable following the procedure, and there were no patient complications reported.
Additional Manufacturer Narrative
Model number/catalog number: 720182-01.Serial number: n/a.Batch/lot number: 0178273001.Model/catalog description: reservoir flat 100 ml.Unique identifier (udi) #: (b)(4).Model number/catalog number: 72404310.Serial number: n/a.Batch/lot number: 0176309003.Model/catalog description: pump ms.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.Inflation issue and fluid leakage are acknowledged within the instructions for use (ifu) and is not related to off label use or failure to follow instructions.A risk review was completed using d055985 ams700 hazard analysis and confirmed that the event of "mechanical malfunction (leaks, incomplete inflation/ deflation, kinking)" was 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 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.

• 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 ; +1(508)652-1217
• MDR Report Key: 25588548
• Report Number: 2124215-2026-33244
• Device Sequence Number: 10286750
• Product Code: JCW
• UDI-Device Identifier: 00878953002705
• UDI-Public: (01)00878953002705(17)220707(10)179150006
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 08/05/2026

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: 07/07/2022
• Device Model Number: 72404013
• Device Catalogue Number: 72404013
• Device Lot Number: 0179150006
• Was Device Available for Evaluation?: No
• 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: 06/12/2026
• Supplement Date Received by Manufacturer: 07/21/2026
• Initial Report FDA Received Date: 06/22/2026
• Supplement Report FDA Received Date: 08/05/2026
• Date Device Manufactured: 07/07/2017
• 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: 69 YR
• Patient Sex: Male