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

Model Number	72404013
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	04/21/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Model number/catalog number: 72404310, serial number: n/a, batch/lot number: 1100757852, model/catalog description: pump ms, unique identifier (udi) #: (b)(4).Model number/catalog number: 72404161, serial number: n/a, batch/lot number: 1100764719, model/catalog description: reservoir 65ml pc, unique identifier (udi) #: (b)(4).The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.There was no report of a device performance allegation.Inflammation is acknowledged within the instructions for use (ifu) and is not related to off label use or failure to follow instructions.The reported patient symptom is a known risk associated with this device type and are indicated as such in the instructions for use.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
Event or Problem Description
It was reported that this patient with an inflatable penile prosthesis (ipp) underwent a surgical procedure due to an inflammatory reaction.The physician removed and replaced the device, and there were no further patient complications reported.
Event or Problem Description
It was reported that this patient with an inflatable penile prosthesis (ipp) underwent a surgical procedure due to an inflammatory reaction.The physician removed and replaced the device, and there were no further patient complications reported.
Additional Manufacturer Narrative
Model number/catalog number: 72404310 serial number: n/a batch/lot number: 1100757852 model/catalog description: pump ms unique identifier (udi) #: (b)(4) model number/catalog number: 72404161 serial number: n/a batch/lot number: 1100764719 model/catalog description: reservoir 65ml pc unique identifier (udi) #: (b)(4) the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.There was no report of a device performance allegation.Inflammation is acknowledged within the instructions for use (ifu) and is not related to off label use or failure to follow instructions.The reported patient symptom is a known risk associated with this device type and are indicated as such in the instructions for use.The device history record (dhr) confirmed that the device met all material, assembly and performance specifications.A risk review confirmed that the event of inflammation was 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, a conclusion code of adverse event related to patient procedure was assigned to this investigation, due to the reason for the inflammation reaction was most likely due to a possible infection or reaction.As the physician replaced the device with another ipp, it is likely that the inflammatory reaction was not caused by the device itself.

• 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: 25166476
• Report Number: 2124215-2026-26004
• Device Sequence Number: 16093630
• Product Code: JCW
• UDI-Device Identifier: 00878953002705
• UDI-Public: (01)00878953002705(17)300731(10)1100771271
• 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: 2026
• 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 Model Number: 72404013
• Device Catalogue Number: 72404013
• Device Lot Number: 1100771271
• 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: 04/21/2026
• Supplement Date Received by Manufacturer: 07/21/2026
• Initial Report FDA Received Date: 05/13/2026
• Supplement Report FDA Received Date: 08/05/2026
• Date Device Manufactured: 08/01/2025
• 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: 62 YR
• Patient Sex: Male