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

Model Number	72404272
Medical Device Problem Codes	Material Puncture/Hole (1504); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2025
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).
Event or Problem Description
It was reported that during a surgical procedure, it was confirmed that there was a crack in the inflatable penile prosthesis (ipp) right cylinder connecting tube, the right cylinder and a pump were replaced according to the doctor diagnosis.There were no patient complications.
Additional Manufacturer Narrative
Upon receipt of this inflatable penile prosthesis at our quality assurance laboratory, this device was thoroughly analyzed.Microscopic analysis identified first cylinder had wear at fold in the proximal end, middle, and distal end of the cylinder.The second cylinder did not present any damage or abnormalities.The device was tested too.Both cylinders successfully passed leakage test.The pump was also tested, identifying under a microscope observation that the pump was contaminated for bodily fluids; the pump tubing was also cut down to the pump block; however, the tubing did not return to analysis.The pump passed leakage test and to avoid damaging the test equipment, the pump was not functionally tested.The allegation of a hole/perforation was not confirmed.Based on review of all information available and analysis results, a conclusion code of cause not established was assigned to this investigation.Concomitant product udi for pump is (b)(4).Concomitant product udi for reservoir is (b)(4).
Event or Problem Description
It was reported that during a surgical procedure, it was confirmed that there was a crack in the inflatable penile prosthesis (ipp) right cylinder connecting tube, the right cylinder and a pump were replaced according to the doctor diagnosis.There were no patient complications.

• Brand Name: AMS 700 CX
• 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: 21809330
• Report Number: 2124215-2025-21741
• Device Sequence Number: 8973937
• Product Code: JCW
• UDI-Device Identifier: 00878953003795
• UDI-Public: (01)00878953003795(17)200818(10)100251004
• 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: 2015
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2025

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: 08/18/2020
• Device Model Number: 72404272
• Device Catalogue Number: 72404272
• Device Lot Number: 100251004
• 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: 03/25/2025
• Supplement Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 04/09/2025
• Supplement Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2015
• 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: PUMP: UPN: 72404310, LOT: 100254001; PUMP: UPN: 72404310, LOT: 100254001; RESERVOIR: UPN: 72404161, LOT: 100182013; RESERVOIR: UPN: 72404161, LOT: 100182013
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male