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	10/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) was not working.It was confirmed that the cylinder had a tear.The device was removed and replaced.The original reservoir was kept in the patient.There were no patient complications.
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) was not working.It was confirmed that the cylinder had a tear.The device was removed and replaced.The original reservoir was kept in the patient.There were no patient complications.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a thorough analysis.The cylinders were microscopically inspected, and leak tested.The first cylinder had a tear in the outer tubing from wear.The first cylinder had wear at a fold in the distal end of the cylinder.The first cylinder passed the leakage testing.The second cylinder had the outer tubing removed.The second cylinder had a hole with a leak at a corner of a fold in the middle of the cylinder.The second cylinder had broken fabric threads from wear in the proximal end of the cylinder.The pump was microscopically inspected, and leak, functionally tested.The microscope test revealed that the pump kink resistant tubing (krt) was worn to the filament.The pump passed the leakage testing.The pump did not pass the activation testing.

• 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: 20686798
• Report Number: 2124215-2024-71674
• Device Sequence Number: 7230016
• 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: 2019
• 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): 01/23/2025

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: 01/24/2023
• Device Model Number: 72404273
• Device Catalogue Number: 72404273
• Device Lot Number: 1000031150
• 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: 10/29/2024
• Supplement Date Received by Manufacturer: 01/02/2025
• Initial Report FDA Received Date: 11/14/2024
• Supplement Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2018
• 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: 7240182-01 / 1000161538 / RESERVOIR; 7240182-01 / 1000161538 / RESERVOIR; 72404310 / 1000105200 / PUMP MS; 72404310 / 1000105200 / PUMP MS
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male