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

Model Number	72404256
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Erosion (1750)
Date of Event	06/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the reservoir of the inflatable penile prosthesis (ipp) had herniated into the patient's scrotum.During the surgical procedure, the physician inflated the cylinders after removing the reservoir from the scrotum and discovered that the right cylinder had eroded into the urethra.A cystoscopy was performed, confirming the erosion, and the replacement procedure was subsequently aborted.A new conceal-type reservoir was placed in the space of retzius.The eroded right cylinder was removed, while the existing left cylinder and the pump were left in place.A follow-up revision surgery is planned once the urethra has adequately healed.No additional patient complications have been reported at this time.
Additional Manufacturer Narrative
D4.Concomitant product udi for reservoir is (b)(4).
Event or Problem Description
It was reported that the reservoir of the inflatable penile prosthesis (ipp) had herniated into the patient's scrotum.During the surgical procedure, the physician inflated the cylinders after removing the reservoir from the scrotum and discovered that the right cylinder had eroded into the urethra.A cystoscopy was performed, confirming the erosion, and the replacement procedure was subsequently aborted.A new conceal-type reservoir was placed in the space of retzius.The eroded right cylinder was removed, while the existing left cylinder and the pump were left in place.A follow-up revision surgery is planned once the urethra has adequately healed.No additional patient complications have been reported at this time.
Additional Manufacturer Narrative
D4.Concomitant product udi for reservoir is (b)(4).Correction to field h6: impact codes.
Event or Problem Description
It was reported that the reservoir of the inflatable penile prosthesis (ipp) had herniated into the patient's scrotum.During the surgical procedure, the physician inflated the cylinders after removing the reservoir from the scrotum and discovered that the right cylinder had eroded into the urethra.A cystoscopy was performed, confirming the erosion, and the replacement procedure was subsequently aborted.A new conceal-type reservoir was placed in the space of retzius.The eroded right cylinder was removed, while the existing left cylinder and the pump were left in place.A follow-up revision surgery is planned once the urethra has adequately healed.No additional patient complications have been reported at this time.
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.There was no report of a device performance allegation.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.The reported patient symptom is a known risk associated with this device type and indicated as such in the instructions for use.D4.Concomitant product udi for reservoir is (b)(4).
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.There was no report of a device performance allegation.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.The reported patient symptom is a known risk associated with this device type and indicated as such in the instructions for use.D4.Concomitant product udi for reservoir is (b)(4).
Event or Problem Description
It was reported that the reservoir of the inflatable penile prosthesis (ipp) had herniated into the patient's scrotum.During the surgical procedure, the physician inflated the cylinders after removing the reservoir from the scrotum and discovered that the right cylinder had eroded into the urethra.A cystoscopy was performed, confirming the erosion, and the replacement procedure was subsequently aborted.A new conceal-type reservoir was placed in the space of retzius.The eroded right cylinder was removed, while the existing left cylinder and the pump were left in place.A follow-up revision surgery is planned once the urethra has adequately healed.No additional patient complications have been reported at this time.

• Brand Name: AMS 700 LGX 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: 22378832
• Report Number: 2124215-2025-43368
• Device Sequence Number: 20972472
• Product Code: JCW
• UDI-Device Identifier: 00878953003641
• UDI-Public: (01)00878953003641(17)160924(10)901731003
• Combination Product (Y/N): Y
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2025
• 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): 01/29/2026

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: 09/24/2016
• Device Model Number: 72404256
• Device Catalogue Number: 72404256
• Device Lot Number: 901731003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2025
• Supplement Date Received by Manufacturer: 07/16/2025; 01/06/2026; 01/06/2026
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 07/16/2025; 01/26/2026; 01/29/2026
• Date Device Manufactured: 10/14/2014
• 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: Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male