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

Model Number	72404011
Medical Device Problem Codes	Mechanical Problem (1384); Nonstandard Device (1420); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant product udi for reservoir is (b)(4), concomitant product udi for pump is (b)(4).
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 the left cylinder had a hole, so both cylinders were replaced.The cause of the cylinder hole was not detailed by the hospital.There were no patient complications reported.
Additional Manufacturer Narrative
Concomitant product udi for reservoir is (b)(4).Concomitant product udi for pump is (b)(4).Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a thorough analysis.The first cylinder was microscopically inspected and leak tested.Microscope examination revealed that the first cylinder had a hole in the proximal end of the cylinder consistent with sharp instrument damage.The first cylinder also had wear at a fold in the proximal end and distal end of the cylinder.The leakage test revealed that the first cylinder had a leak in the proximal end of the cylinder.The second cylinder was microscopically inspected and leak tested.No damage or abnormalities were found, and the second cylinder passed the leakage test.Based on the available test results and investigation, the allegation of mechanical issue and hole/perforation could not be confirmed.The sharp instrument damage identified on the first cylinder is consistent with a secondary event that occurred during the explant procedure and does not support the reported complaint.The device history record (dhr) review confirmed that the device met all material, assembly, and performance specifications.A review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.Based on the information available, a conclusion code of cause not established was assigned to this investigation.
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 the left cylinder had a hole, so both cylinders were replaced according to the doctors diagnosis.The cause of the cylinder hole was not detailed by the hospital.There were no patient complications reported.
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 the left cylinder had a hole, so both cylinders were replaced according to the doctors diagnosis.The cause of the cylinder hole was not detailed by the hospital.There were no patient complications reported.
Additional Manufacturer Narrative
Concomitant product udi for reservoir is (b)(4).Concomitant product udi for pump is (b)(4).Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a thorough analysis.The first cylinder was microscopically inspected and leak tested.Microscope examination revealed that the first cylinder had a hole in the proximal end of the cylinder consistent with sharp instrument damage.The first cylinder also had wear at a fold in the proximal end and distal end of the cylinder.The leakage test revealed that the first cylinder had a leak in the proximal end of the cylinder.The second cylinder was microscopically inspected and leak tested.No damage or abnormalities were found, and the second cylinder passed the leakage test.Based on the available test results and investigation, the allegation of mechanical issue and hole/perforation could not be confirmed.The sharp instrument damage identified on the first cylinder is consistent with a secondary event that occurred during the explant procedure and does not support the reported complaint.The device history record (dhr) review confirmed that the device met all material, assembly, and performance specifications.A review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.Based on the information available, a conclusion code of cause not established was assigned to this investigation.

• Brand Name: AMS 700 CXR
• 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: 22889634
• Report Number: 2124215-2025-59256
• Device Sequence Number: 4849385
• Product Code: JCW
• UDI-Device Identifier: 00878953002682
• UDI-Public: (01)00878953002682(17)281011(10)1100373805
• 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: 2022
• 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,Followup
• Report Date (Section B): 02/19/2026

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: 72404011
• Device Catalogue Number: 72404011
• Device Lot Number: 1100373805
• 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: 07/31/2025
• Supplement Date Received by Manufacturer: 10/20/2025; 01/29/2026
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 11/17/2025; 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2023
• 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: UPN: 72404310 / LOT: 1100524580; PUMP: UPN: 72404310 / LOT: 1100524580; PUMP: UPN: 72404310 / LOT: 1100524580; RESERVOIR: UPN: 72404161 / LOT: 1100452538; RESERVOIR: UPN: 72404161 / LOT: 1100452538; RESERVOIR: UPN: 72404161 / LOT: 1100452538
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Male