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

Model Number	72404239
Medical Device Problem Codes	Nonstandard Device (1420); Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Codes	Erosion (1750); Discomfort (2330)
Date of Event	10/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) experienced erosion in the right corporotomy, and migration of the right cylinder from the right corporotomy to the scrotum, as he started using the device prior the recovery period.A revision surgery was performed, and it was noted that, in addition, the right cylinder was too large for patient's anatomy; therefore, the component was removed and replaced with a smaller one.There were no further patient complications reported.
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) experienced erosion in the right corporotomy, and migration of the right cylinder from the right corporotomy to the scrotum, as he started using the device prior the recovery period.A revision surgery was performed, and it was noted that, in addition, the right cylinder was too large for patient's anatomy; therefore, the component was removed and replaced with a smaller one.There were no further patient complications reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, the returned component underwent a thorough analysis.The cylinder was microscopically inspected and tested for leaks.Microscopic examination revealed that the proximal end of the cylinder was cut by a sharp instrument, and the middle portion of the component exhibited wear at fold.The reported erosion, migration and length too long are known risks associated with implant of these device as indicated in the instructions for use (ifu).
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) experienced discomfort and erosion in the right corporotomy, along with migration of the right cylinder from the right corporotomy to the scrotum, as he started using the device prior the recovery period.A revision surgery was performed, and it was noted that, in addition, the right cylinder was too large for patient's anatomy; therefore, the component was removed and replaced with a smaller one.There were no further patient complications reported.
Additional Manufacturer Narrative
Correction to field b5: describe event or problem.Correction to field h6: patient codes.Upon receipt at our quality assurance laboratory, the returned component underwent a thorough analysis.The cylinder was microscopically inspected and tested for leaks.Microscopic examination revealed that the proximal end of the cylinder was cut by a sharp instrument, and the middle portion of the component exhibited wear at fold.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.A risk review was completed and confirmed that the events of "erosion", "length too long", and "migration" were defined in the product risk documentation.This event type has been accounted for during analysis to support acceptable risk benefit for the product.The reported erosion, migration and length too long are known risks associated with implant of these device as indicated in the instructions for use (ifu); therefore, a conclusion code of known inherent risk of device was assigned to this investigation.
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) experienced discomfort and erosion in the right corporotomy, along with migration of the right cylinder from the right corporotomy to the scrotum, as he started using the device prior the recovery period.A revision surgery was performed, and it was noted that, in addition, the right cylinder was too large for patient's anatomy; therefore, the component was removed and replaced with a smaller one.There were no further patient complications reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, the returned component underwent a thorough analysis.The cylinder was microscopically inspected and tested for leaks.Microscopic examination revealed that the proximal end of the cylinder was cut by a sharp instrument, and the middle portion of the component exhibited wear at fold.No leaks were identified.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.A risk review was completed and confirmed that the events of "erosion", "discomfort", "length too long", and "migration" were defined in the product risk documentation.This event type has been accounted for during analysis to support acceptable risk benefit for the product.The reported erosion, discomfort, migration and length too long are known risks associated with implant of these device as indicated in the instructions for use (ifu); therefore, a conclusion code of known inherent risk of device was assigned to this investigation.

• 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: 20471842
• Report Number: 2124215-2024-64898
• Device Sequence Number: 12665732
• Product Code: JCW
• UDI-Device Identifier: 00878953003528
• UDI-Public: 00878953003528
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/16/2026

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 Expiration Date: 10/13/2024
• Device Model Number: 72404239
• Device Catalogue Number: 72404239
• Device Lot Number: 1100201274
• 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: 10/01/2024
• Supplement Date Received by Manufacturer: 11/14/2024; 03/23/2026; 04/16/2026
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 12/03/2024; 03/30/2026; 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Unknown