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

Model Number	72404273
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	01/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that two weeks before the operation, the patient went to the hospital, and it was confirmed that the left cylinder had a hole.Due to this, a surgical procedure was performed to replace the cylinder and pump.There were no patient complications.
Additional Manufacturer Narrative
Correction to field b3: date of event.Upon receipt of this inflatable penile prosthesis at our quality assurance laboratory, this device was thoroughly analyzed.Microscopic analysis identified the cylinder presented two holes in the outer tube at the corner of two folds from wear in the proximal end of the cylinder.The device was functionally tested too, concluding the cylinder did not pass the leakage test due to a leak from the krt (kink resistant tubing) from wear.The pump was analyzed too, confirming its tubing was cut down to the pump block and passing the leakage test but, the functional test for pump did not pass.The allegation of a hole in the left cylinder was confirmed.Based on the information provided, cause traced to component failure was selected as the most probable cause for the complaint.Concomitant product udi for pump is (b)(4).
Event or Problem Description
It was reported that the patient went to the hospital, and it was confirmed that the left cylinder had a hole.Two weeks later, a surgical procedure was performed to replace the cylinder and pump.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: 21493786
• Report Number: 2124215-2025-12354
• Device Sequence Number: 20938407
• Product Code: JCW
• UDI-Device Identifier: 00878953003801
• UDI-Public: (01)00878953003801(17)271102(10)1100210226
• 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: 2023
• 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): 05/26/2025

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 Model Number: 72404273
• Device Catalogue Number: 72404273
• Device Lot Number: 1100210226
• 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: 02/13/2025
• Supplement Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 02/28/2025
• Supplement Report FDA Received Date: 05/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2022
• 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: 1100257370, UPN: 72404310.; PUMP: LOT: 72404310.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male