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

Model Number	72404282
Medical Device Problem Codes	Inflation Problem (1310); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Adhesion(s) (1695)
Date of Event	12/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after the implantation of an inflatable penile prosthesis (ipp), the pump adhered to the skin and the cylinder could not be fully inflated.Upon revision, it was determined that the patient needed to have the ipp removed and replaced with a new one.Due to the replacement surgery, it was necessary to prolong the patient's hospitalization to prevent an infection.No further patient complications were reported.
Event or Problem Description
It was reported that after the implantation of an inflatable penile prosthesis (ipp), the pump adhered to the skin and the cylinder could not be fully inflated.Upon revision, it was determined that the patient needed to have the ipp removed and replaced with a new one because the pump stayed flat.Due to the replacement surgery, it was necessary to prolong the patient's hospitalization to prevent an infection.No further patient complications were reported.
Event or Problem Description
It was reported that after the implantation of an inflatable penile prosthesis (ipp), the pump adhered to the skin and the cylinder could not be fully inflated.Upon revision, it was determined that the patient needed to have the ipp removed and replaced with a new one because the pump stayed flat.Due to the replacement surgery, it was necessary to prolong the patient's hospitalization to prevent an infection.No further patient complications were reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a thorough analysis.Both cylinders were microscopically, and leak tested.Microscope examination revealed that the first cylinder had a hole in the proximal end of the cylinder from sharp instrument.First cylinder had wear at fold in the proximal end and distal end of the cylinder.First cylinder had a leak from sharp instrument in the proximal end of the cylinder.Microscope examination revealed that the second cylinder had wear at fold in the proximal end, middle, and distal end of the cylinder.The second cylinder passed the leakage test.The pump was microscopically inspected, leak and functionally tested.The pump passed the microscope examination, leakage and functional test.Both rear tip extenders (rte) were visually inspected.Both rtes passed visual inspection.No damage or abnormalities were found.Based on the information available and analysis results, the investigation conclusion code of known inherent risk of device was chosen as the allegation related to adhesions which is addressed in the labeling and risk documentation.

• Brand Name: AMS 700 CX MS PUMP
• 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: 21150050
• Report Number: 2124215-2024-83940
• Device Sequence Number: 15864440
• Product Code: JCW
• UDI-Device Identifier: 00878953003856
• UDI-Public: 00878953003856
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/25/2025

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: 72404282
• Device Catalogue Number: 72404282
• Device Lot Number: 1100585704
• 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: 12/20/2024
• Supplement Date Received by Manufacturer: 01/23/2025; 03/04/2025
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 02/13/2025; 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 70 KG