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

Model Number	72404253-12
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant product udi for reservoir is (b)(4).The device is not available for analysis; therefore, no physical analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Based on the information available the cause that contributed to the reported event cannot be established.
Event or Problem Description
It was reported that the patient's inflatable penile prosthesis (ipp) exhibited fluid loss.A surgical procedure was performed, during which fluid loss was confirmed at the mid-cylinder area, due to a hole.The ipp was replaced, and no patient complications were reported.
Additional Manufacturer Narrative
Model number/catalog number: 72404156.Serial number: n/a.Batch/lot number: 1100518422.Model/catalog description: reservoir 100 ml pc/iz.Unique identifier (udi) #: (b)(4).Upon receipt at the quality assurance laboratory, the returned components underwent a thorough analysis.The pump was visually inspected and leak tested.Microscopic examination revealed contamination (bodily fluid) within the ms pump.Due to this contamination, fluid was unable to flow properly into and out of the internal ms pump system during the leak test.The first cylinder was visually inspected, leak tested, and pressure tested.Visual inspection showed that the outer tube had a hole located in the middle portion of the cylinder, consistent with damage caused by a sharp instrument.Despite this damage, the first cylinder passed both the leak and pressure tests.The second cylinder was visually inspected, leak tested, and pressure tested.Visual inspection revealed holes in the outer tube in the middle portion of the cylinder, also consistent with sharp instrument damage.The second cylinder passed both the leak and pressure tests.The reservoir was visually inspected and passed the evaluation.No damage or abnormalities were observed.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.A risk review was completed and confirmed that the event of fluid leak and hole/perforate was defined in the product risk documentation.This event type has been accounted for during analysis to support acceptable risk benefit for the product.Based on the information available, the cause that contributed to the reported event cannot be excluded as a device related problem.The allegations of a hole/perforation and fluid leakage could not be confirmed.Additionally, to avoid damaging the test equipment, the contaminated ms pump was not functionally tested.Therefore, a conclusion code of unable to exclude device problem was assigned to this investigation.
Event or Problem Description
It was reported that the patient's inflatable penile prosthesis (ipp) exhibited fluid loss.A surgical procedure was performed, during which fluid loss was confirmed at the mid-cylinder area, due to a hole.The ipp was replaced, and no patient complications were reported.
Additional Manufacturer Narrative
Correction to field e1 initial reporter phone.Model number/catalog number: 72404156.Serial number: n/a.Batch/lot number: 1100518422.Model/catalog description: reservoir 100 ml pc/iz.Unique identifier (udi) #: (b)(4).Upon receipt at the quality assurance laboratory, the returned components underwent a thorough analysis.The pump was visually inspected and leak tested.Microscopic examination revealed contamination (bodily fluid) within the ms pump.Due to this contamination, fluid was unable to flow properly into and out of the internal ms pump system during the leak test.The first cylinder was visually inspected, leak tested, and pressure tested.Visual inspection showed that the outer tube had a hole located in the middle portion of the cylinder, consistent with damage caused by a sharp instrument.Despite this damage, the first cylinder passed both the leak and pressure tests.The second cylinder was visually inspected, leak tested, and pressure tested.Visual inspection revealed holes in the outer tube in the middle portion of the cylinder, also consistent with sharp instrument damage.The second cylinder passed both the leak and pressure tests.The reservoir was visually inspected and passed the evaluation.No damage or abnormalities were observed.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.A risk review was completed and confirmed that the event of fluid leak and hole/perforate was defined in the product risk documentation.This event type has been accounted for during analysis to support acceptable risk benefit for the product.Based on the information available, the allegations of a hole/perforation and fluid leakage could not be confirmed.Additionally, to avoid damaging the test equipment, the contaminated ms pump was not functionally tested.Therefore, a conclusion code of unable to exclude device problem was assigned to this investigation.
Event or Problem Description
It was reported that the patient's inflatable penile prosthesis (ipp) exhibited fluid loss.A surgical procedure was performed, during which fluid loss was confirmed at the mid-cylinder area, due to a hole.The ipp was replaced, and no patient complications were reported.

• 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: 23995199
• Report Number: 2124215-2026-01064
• Device Sequence Number: 10184682
• Product Code: JCW
• UDI-Device Identifier: 00878953009827
• UDI-Public: (01)00878953009827(17)270121(10)1100660005
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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
• Report Date (Section B): 04/09/2026

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: 72404253-12
• Device Catalogue Number: 72404253-12
• Device Lot Number: 1100660005
• 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: 12/18/2025
• Supplement Date Received by Manufacturer: 02/13/2026; 03/24/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 03/13/2026; 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2025
• 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: RESERVOIR: UPN: 72404156 / LOT: 1100518422.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male