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

Model Number	72404231
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	01/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) was not working.Upon examination, a distal perforation was discovered which was not caused by the surgeon at the time of operation; therefore, the case was aborted.No patient complications were reported.
Additional Manufacturer Narrative
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.The patient symptom is a known risk associated with this device type/procedure, and it is noted as such as in the instructions for use.
Additional Manufacturer Narrative
Model number/catalog number 720185-01, batch/lot number 102414016, model/catalog description reservoir flat iz 100 ml, unique identifier (udi) # (b)(4).The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The device history record (dhr) review was unable to be performed as the lot number was not provided.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.The reported patient symptom of perforation is a known risk associated with this device type and indicated as such in the instructions for use.A risk review was completed and confirmed that the event of perforation and mechanical issue 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 known inherent risk was assigned to this investigation.
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) was not working.Upon examination, a distal perforation was discovered which was not caused by the surgeon at the time of operation; therefore, the case was aborted.No patient complications were reported.
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) was not working.Upon examination, a distal perforation was discovered which was not caused by the surgeon at the time of operation; therefore, the case was aborted.No patient complications were reported.
Additional Manufacturer Narrative
Correction to field h6: evaluation conclusion codes correction to field h11: additional mfr narrative.Model number/catalog number 720185-01.Serial number n/a.Batch/lot number 102414016.Model/catalog description reservoir flat iz 100 ml unique identifier (udi) # (b)(4) the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.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.The reported patient symptom of perforation is a known risk associated with this device type and indicated as such in the instructions for use.A risk review was completed and confirmed that the event of perforation and mechanical issue 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 unable to exclude device problem was assigned to this investigation.

• Brand Name: AMS 700 CX 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: 24223401
• Report Number: 2124215-2026-05571
• Device Sequence Number: 8085593
• Product Code: JCW
• UDI-Device Identifier: 00878953003443
• UDI-Public: (01)00878953003443(17)170320(10)928355002
• Combination Product (Y/N): Y
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/20/2026

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: 03/20/2017
• Device Model Number: 72404231
• Device Catalogue Number: 72404231
• Device Lot Number: 928355002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2026
• Supplement Date Received by Manufacturer: 02/25/2026; 03/24/2026
• Initial Report FDA Received Date: 01/30/2026
• Supplement Report FDA Received Date: 03/24/2026; 04/20/2026
• 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: RESERVOIR: UPN: 720185-01 / LOT: 102414016.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 80 YR
• Patient Sex: Male