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

Model Number	72404272
Medical Device Problem Codes	Mechanical Problem (1384); 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	05/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Udi field (d4) concomitant product udi for pump is (b)(4).Udi field (d4) concomitant product udi for reservoir is (b)(4).
Event or Problem Description
It was reported that a patient with an inflatable penile prosthesis ipp presented with a nonfunctioning device.A revision surgery was performed, during which the physician confirmed a crack in the right cylinder connecting tube.As a result, both cylinders and the pump were replaced.No patient complications were reported.
Additional Manufacturer Narrative
Udi field (d4) concomitant product udi for pump is (b)(4).Udi field (d4) concomitant product udi for reservoir is (b)(4).Upon receipt at the quality assurance laboratory, the returned components underwent a comprehensive evaluation.Microscope inspection revealed the first cylinder had a hole at the corner of a fold in the proximal end and wear at the fold in the proximal end and middle of the cylinder.Leakage testing of the first cylinder found there was a fluid leak from the location of the hole in the proximal end.Microscopic inspection revealed the second cylinder had wear at the fold in the proximal end and middle of the cylinder.Leakage testing of the second cylinder found there were no fluid leaks.Microscope inspection revealed the ms pump kink resistant tubing (krt) had wear to the filament and did not pass the test.Leakage and functional testing for the ms pump were passed.Based on the information available and analysis results, the allegations of mechanical issue and hole/perforation were most likely determined to be due to the leak from the corner of a fold in first cylinder.A conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that a patient with an inflatable penile prosthesis (ipp) presented with a nonfunctioning device.A revision surgery was performed, during which the physician confirmed a crack in the right cylinder connecting tube.As a result, both cylinders and the pump were replaced.No patient complications were reported.

• 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: 22414157
• Report Number: 2124215-2025-44327
• Device Sequence Number: 9664485
• Product Code: JCW
• UDI-Device Identifier: 00878953003795
• UDI-Public: (01)00878953003795(17)200818(10)100253005
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2025

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: 100253005
• 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: 06/12/2025
• Supplement Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 10/23/2025
• 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 LOT 104461002, UPN 72404310.; PUMP LOT 104461002, UPN 72404310.; RESERVOIR LOT 107471014, UPN 72404161.; RESERVOIR LOT 107471014, UPN 72404161.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male