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

Model Number	72404251
Medical Device Problem Codes	Collapse (1099); Deflation Problem (1149); Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a surgical implantation procedure of an inflatable penile prosthesis (ipp), an issue was identified during device preparation.The device did not inflate properly and exhibited a significant delay in recoil.The device was eventually prepared; however, additional issues were noted intraoperatively.After insertion and test inflation, the device did not deflate.The expected deflation "buzz" was not observed and continued to demonstrate very slow recoil during inflation.The device was cycled approximately ten times with no improvement, and multiple troubleshooting techniques were attempted, including squeezing the pump block; however, the issue persisted.As a result, the device was not used to complete the procedure.An alternative device was used.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: 25829171
• Report Number: 2124215-2026-38023
• Device Sequence Number: 9999500
• Product Code: JCW
• UDI-Device Identifier: 00878953003597
• UDI-Public: (01)00878953003597(17)280417(10)1100956618
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 72404251
• Device Catalogue Number: 72404251
• Device Lot Number: 1100956618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2026
• Initial Report FDA Received Date: 07/15/2026
• Date Device Manufactured: 04/18/2026
• 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
• Patient Sex: Unknown