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

Model Number	72404272
Medical Device Problem Codes	Inflation Problem (1310); 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	02/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented with an inability to inflate his inflatable penile prosthesis device.A revision surgery was performed in which the physician confirmed that the cylinder had a tear.The device was explanted and replaced.There were no patient complications.
Event or Problem Description
It was reported that the patient presented with an inability to inflate his inflatable penile prosthesis (ipp) device.A revision surgery was performed in which the physician confirmed that the cylinder had a tear.The device was explanted and replaced.There were no patient complications.
Additional Manufacturer Narrative
Concomitant product/therapy (c2/d10): reservoir (b)(4).Upon receipt at our post market quality assurance laboratory, this inflatable penile prosthesis (ipp) was thoroughly analyzed.The cylinders were visually and microscopically inspected, and leak tested.Both cylinders exhibited wear at a fold in the proximal and middle sections.A hole was observed in one of the cylinders at the corner of the fold in the middle section.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities that would affect the functionality of the device.Laboratory analysis confirmed the reported clinical observation of inflation difficulty.The observed fatigue damage was determined the most probable cause of the reported events.An overall evaluation conclusion code of cause traced to component failure was assigned to this investigation.
Additional Manufacturer Narrative
Udi field (d4) concomitant product udi for reservoir is (b)(4).Udi field (d4) concomitant product udi for pump is (b)(4).Correction to field b3: date of event.Correction to field b5: describe event or problem.Correction to field g2: report source.Correction to field h6: device codes.Upon receipt at our post market quality assurance laboratory, this inflatable penile prosthesis (ipp) was thoroughly analyzed.The cylinders were microscopically inspected, and leak tested.Both cylinders exhibited wear at a fold in the proximal and middle sections.On once of the cylinders, a hole was also observed at the corner of the fold in the middle section.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities that would affect the functionality of the device.The leak at the corner of a fold in cylinder 1 was the most probable cause of the event.An overall evaluation conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that a patient with an inflatable penile prosthesis ipp presented with a nonfunctioning device.A revision surgery was performed in which the physician confirmed that the cylinder had a tear.The device was explanted and replaced.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: 21761838
• Report Number: 2124215-2025-20435
• Device Sequence Number: 15598967
• Product Code: JCW
• UDI-Device Identifier: 00878953003795
• UDI-Public: (01)00878953003795(17)201009(10)106475005
• 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: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/25/2025

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 Expiration Date: 10/09/2020
• Device Model Number: 72404272
• Device Catalogue Number: 72404272
• Device Lot Number: 0106475005
• 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: 03/12/2025
• Supplement Date Received by Manufacturer: 05/22/2025; 07/04/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 06/19/2025; 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2015
• 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 164379005; PUMP UPN 72404310, LOT 164379005; PUMP UPN 72404310, LOT 164379005; RESERVOIR UPN 72404161, LOT 162435003; RESERVOIR UPN 72404161, LOT 162435003; RESERVOIR UPN 72404161, LOT 162435003
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Male