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

Model Number	72404273
Medical Device Problem Codes	Mechanical Problem (1384); Nonstandard Device (1420); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient with an inflatable penile prosthesis (ipp) presented with a nonfunctioning device.A revision surgery was performed, during which the physician confirmed that there was a crack in the cylinder connecting tube, therefore; both cylinders and the pump were replaced.There were no patient complications.
Additional Manufacturer Narrative
Udi field (d4) concomitant product udi for pump is (b)(4).Udi field (d4) 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.Fluid loss and mechanical malfunction are acknowledged within the dfu and are not related to off-label use or failure to follow instructions.Additionally, it is concluded that the cause of hole/perforated allegations cannot be established without product return.Based on the information available the cause that contributed to the reported event cannot be established.
Additional Manufacturer Narrative
Udi field (d4) concomitant product udi for pump is (b)(4).Udi field (d4) concomitant product udi for reservoir is (b)(4).Upon receipt at the quality assurance laboratory, the returned components underwent a comprehensive evaluation.Visual inspection revealed first cylinder outer tube had a hole caused by a sharp instrument at the proximal end, and second cylinder kink resistant tubing (krt) showed a hole from sharp instrument damage; second cylinder passed the leakage test.The ms pump passed visual inspection with no damage or abnormalities observed and passed the leakage test but failed activation tests 2 and 3.The sharp instrument damage observed on the device is considered a secondary issue; therefore, the allegation of mechanical issue and hole/perforation cannot be confirmed.However, there are several modes that could lead to mechanical issues and hole/perforation, which include but are not limited to device malfunction.Based on the information available and analysis results, the failure of the pump that did not pass the functional activation test 2 and 3 could have caused or contributed to the device being explanted, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that a patient with an inflatable penile prosthesis (ipp) presented with a nonfunctioning device.A revision surgery was performed, during which the physician confirmed that there was a crack in the cylinder connecting tube, therefore; both cylinders and the pump were replaced.There were no patient complications.

• Brand Name: AMS 700 CX
• 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: 23475818
• Report Number: 2124215-2025-77541
• Device Sequence Number: 10329930
• Product Code: JCW
• UDI-Device Identifier: 00878953003801
• UDI-Public: (01)00878953003801(17)220601(10)176305009
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2026

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: 06/01/2022
• Device Model Number: 72404273
• Device Catalogue Number: 72404273
• Device Lot Number: 0176305009
• 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: 10/15/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2017
• 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: PUMP LOT 0178456010, UPN 72404310; PUMP LOT 0178456010, UPN 72404310; RESERVOIR LOT 0178270003, UPN 72018201; RESERVOIR LOT 0178270003, UPN 72018201
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 86 YR
• Patient Sex: Male