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

Model Number	72404273
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	10/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) went to the hospital two weeks before the operation because the product did not work properly.As a result of the inspection, it was confirmed that there was a crack in the reservoir connecting tube.The ipp was explanted and replaced.There were not patient complications reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a thorough analysis.Cylinder one had a hole with a leak in the outer tube from kink resistant tubing (krt) wear in the proximal end.Cylinder 1 had wear at fold in the proximal end, middle, and distal end of the cylinder.The cylinder 1 krt was worn to the filament.Cylinder 2 had wear at fold in the proximal end, middle, and distal end of the cylinder.The cylinder 2 krt was worn to the filament.Cylinder 2 had a leak from sharp instrument in the proximal end of the cylinder.The momentary squeeze (ms) pump krt was worn to the filament.Under microscope observation, contamination was found within the ms pump, therefore it was not functionally tested.The ms pump passed the leakage testing.The flat reservoir had wear and a hole at a fold in reservoir shell.There was a leak at a corner of a fold in flat reservoir shell.
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) went to the hospital two weeks before the operation because the product did not work properly.As a result of the inspection, it was confirmed that there was a crack in the reservoir connecting tube.The ipp was explanted and replaced.There were not patient complications 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: 20674263
• Report Number: 2124215-2024-70804
• Device Sequence Number: 21056199
• Product Code: JCW
• UDI-Device Identifier: 00878953003801
• UDI-Public: 00878953003801
• 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: 2017
• Device Explanted Year: 2024
• 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): 01/08/2025

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: 01/03/2022
• Device Model Number: 72404273
• Device Catalogue Number: 72404273
• Device Lot Number: 0160886004
• 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: 10/23/2024
• Supplement Date Received by Manufacturer: 12/16/2024
• Initial Report FDA Received Date: 11/13/2024
• Supplement Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2017
• 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: 720182-01 / 151509007 / RESERVOIR; 720182-01 / 151509007 / RESERVOIR; 72404310 / 152382005 / PUMP; 72404310 / 152382005 / PUMP
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Male