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

Model Number	72404233
Medical Device Problem Codes	Inflation Problem (1310); Mechanical Problem (1384); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.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 this inflatable penile prosthesis (ipp) presented a mechanical problem.On examination, the cylinders did not fill and remained flaccid.The sleeve collapsed after the second pump, producing a sensation of air in the system, which suggested a fluid leak.Replacement surgery has been schedule.There is no additional information reported.
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.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.Updated lot number d4.
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) presented a mechanical problem.On examination, the cylinders did not fill and remained flaccid.The sleeve collapsed after the second pump, producing a sensation of air in the system, which suggested a fluid leak.Replacement surgery has been schedule.There is no additional information reported.
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) presented a mechanical problem.On examination, the cylinders did not fill and remained flaccid.The sleeve collapsed after the second pump, producing a sensation of air in the system, which suggested a fluid leak.Replacement surgery has been schedule.There is no additional information reported.
Additional Manufacturer Narrative
Upon receipt at the quality assurance laboratory, the returned components underwent a comprehensive evaluation.The first cylinder exhibited wear at a fold in the proximal end of the cylinder, with a hole identified in the outer tube consistent with kink resistant tubing (krt) wear.Additionally, a hole was identified in the middle of the cylinder attributed to contact with a sharp instrument.Broken fabric threads were observed in the same region, and leakage from the cylinder was confirmed at the location of the damage.The second cylinder exhibited wear at a fold in the proximal end of the cylinder, with additional wear noted at the distal end.The second cylinder passed leakage testing.The ms pump krt components were worn to the filament, and one krt exhibited a broken filament extending out of the tubing.The ms pump passed leak testing but did not pass activation tests 2 and 3.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 events of mechanical malfunction (leaks, incomplete inflation and deflation, kinking) and excess force or friction on silicone leading to stress, strains, holes, or tears were defined in the product risk documentation.This event type has been accounted for during analysis to support an acceptable risk benefit for the product.Based on the information available and the analysis results, the mechanical issue and cylinder inflation issue were most likely related to the ms pump not passing activation tests 2 and 3, as well as the first cylinder having a hole in the outer sleeve and broken fabric threads identified during functional testing.The sharp instrument damage observed on the first cylinder likely occurred during the explant surgery and was considered a secondary condition.A conclusion code of cause traced to component failure 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: 24482124
• Report Number: 2124215-2026-11307
• Device Sequence Number: 13165650
• Product Code: JCW
• Combination Product (Y/N): Y
• Initial Reporter Country: DR
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/20/2026

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: 07/06/2024
• Device Model Number: 72404233
• Device Catalogue Number: 72404233
• Device Lot Number: 1100153419
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2026
• Supplement Date Received by Manufacturer: 03/24/2026; 04/22/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 04/13/2026; 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2022
• 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: 66 YR
• Patient Sex: Male