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	05/19/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Model number/catalog number: 72404310.Serial number: n/a.Batch/lot number: 1000162427.Model/catalog description: pump ms.Unique identifier (udi) #: (b)(4).Model number/catalog number: 72404161.Serial number: n/a.Batch/lot number: 1000232131.Model/catalog description: reservoir 65ml pc.Unique identifier (udi) #: (b)(4).
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) presented to the hospital with a non-functional device.Two weeks later, a surgical procedure was performed and upon inspection, there was a hole found in the left cylinder.As a result, the physician removed and replaced the entire ipp.The patient was stable following the procedure, and there was no additional information 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 ; +1(508)652-1217
• MDR Report Key: 25555722
• Report Number: 2124215-2026-32811
• Device Sequence Number: 15955735
• Product Code: JCW
• UDI-Device Identifier: 00878953002699
• UDI-Public: (01)00878953002699(17)240115(10)1000211851
• 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: 2019
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/29/2026

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: 01/15/2024
• Device Model Number: 72404012
• Device Catalogue Number: 72404012
• Device Lot Number: 1000211851
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/14/2026
• 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: 06/03/2026
• Supplement Date Received by Manufacturer: 07/06/2026; 09/22/2026
• Initial Report FDA Received Date: 06/18/2026
• Supplement Report FDA Received Date: 07/08/2026; 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2019
• 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: 75 YR
• Patient Sex: Male