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

Model Number	72404238
Medical Device Problem Codes	Inflation Problem (1310); Mechanical Problem (1384); Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Udi field (d4) concomitant product udi for reservoir is (b)(4).
Event or Problem Description
It was reported that a patient with an inflatable penile prosthesis (ipp) presented with a nonfunctioning pump.A revision surgery was performed, during which the physician confirmed that the pump was not fully inflating and was automatically deflating.When attempting to pump, after three to four pumps, the pump would become firm, and the physician was unable to pump further.The physician also stated that no air was observed in the device, and the bulb did not remain flat during assessment.The patient's implant was not achieving full erection.Intraoperatively, the reservoir was tested and contained the correct amount of fluid (100 cc), and no leaks were identified; therefore, the physician decided to replace all components except the reservoir.There were no patient complications.
Event or Problem Description
It was reported that a patient with an inflatable penile prosthesis (ipp) presented with a nonfunctioning pump, stating that it was not fully inflating and was automatically deflating.A revision surgery was performed, and when attempting to pump, after three to four pumps, the pump would become firm, and the physician was unable to pump further.The physician also stated that no air was observed in the device, and the bulb did not remain flat during assessment.The patient's implant was not achieving full erection.Intraoperatively, the reservoir was tested and contained the correct amount of fluid (100 cc), and no leaks were identified; therefore, the physician decided to replace all components except the reservoir.There were no patient complications.
Additional Manufacturer Narrative
Model number/catalog number: 72018501.Serial number: n/a.Batch/lot number: 1100580375.Model/catalog description: reservoir flat iz 100 ml.Unique identifier (udi) #: (b)(4).Correction to field b5: describe event or problem.Upon receipt at our quality assurance laboratory, the returned components underwent a thorough analysis.Both cylinders passed visual inspection, and no damage or abnormalities were identified.Both cylinders passed the leakage test.The ms pump passed visual inspection, and no damage or abnormalities were identified.The ms pump passed leak testing and passed functional testing.The cylinders and pump were connected, and the cylinders were fully inflated and deflated with no issues detected.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 mechanical malfunction (leaks, incomplete inflation/ deflation, kinking) 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 and analysis results, the reported allegations of pump inflation issue, pump mechanical issue, and pump spontaneous deflation could not be confirmed.Therefore, a conclusion code of no problem detected 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: 24434613
• Report Number: 2124215-2026-10261
• Device Sequence Number: 10298241
• Product Code: JCW
• UDI-Device Identifier: 00878953003511
• UDI-Public: (01)00878953003511(17)270709(10)1100757541
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• 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: 2026
• 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
• Report Date (Section B): 03/31/2026

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: 72404238
• Device Catalogue Number: 72404238
• Device Lot Number: 1100757541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2026
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2025
• 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 LOT 1100580375, UPN 72018501
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male