MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 700 CX; prosthesis, penis, inflatable

Model Number	72404272
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	12/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant product udi for pump 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 visited the hospital because his inflatable penile prosthesis (ipp) was not functioning properly.The patient underwent surgery two weeks later and upon inspection, a crack was identified in the cylinder and the pump connecting tube.Both the cylinder and the pump were explanted and replaced.There were no patient complications reported.
Event or Problem Description
It was reported that the patient visited the hospital because his inflatable penile prosthesis (ipp) was not functioning properly.The patient underwent surgery two weeks later and upon inspection, a crack was identified in the cylinder and the pump connecting tube.Both the cylinder and the pump were explanted and replaced.There were no patient complications reported.
Additional Manufacturer Narrative
Model number/catalog number: 72404310.Serial number: n/a.Batch/lot number: 1100204381.Model/catalog description: pump ms.Unique identifier (udi) #: (b)(4).Upon receipt at our quality assurance laboratory, this ams 700 underwent a thorough analysis.The cylinders were microscopically inspected and leak tested.Upon examination, the fist cylinder had a hole at the corner of a fold in the proximal end of the cylinder and wear at fold in the proximal end and middle of the cylinder.The second cylinder exhibited wear at fold in the middle of the component.Upon leakage test, the fist cylinder did not pass the test, due to the leak at the corner of the fold in the proximal end of the component, while the second component passed the test.The pump component was microscopically inspected, leak and functionally tested.During examination, the pump passed the visual inspection as no damage or abnormality could be identified.The pump passed the leakage test; however, upon functional testing the pump could not pass the activation tests two and three.Based on the information available and analysis results, the hole identified in the cylinder and the pump not passing the activation tests could have caused or contributed to the reported clinical observation of the device not working properly and the crack in the cylinder.A conclusion code of cause traced to component failure was assigned to the investigation.This report is report is being submitted to correct the adverse event/product problem field (b1) in section b, adverse event/product problem this record was identified during a retrospective review of complaint events; an electronic medical device report (emdr) was not previously submitted per applicable reporting criteria.Boston scientific has opened a nonconforming events and prevention investigation (ncep-00181844) to determine the potential cause for why an emdr was not previously submitted to the food and drug administration (fda) in accordance with boston scientific's established medical device reporting process and fda adverse event reporting requirements.Information gained through these investigation efforts will be utilized to take action(s), as necessary.

• 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: 24266368
• Report Number: 2124215-2026-06544
• Device Sequence Number: 18808855
• Product Code: JCW
• 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: 2023
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/19/2023
• Device Model Number: 72404272
• Device Catalogue Number: 72404272
• Device Lot Number: 1000207587
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/24/2026
• 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: 01/06/2026
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2018
• 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: UPN: 72404310 / Lot: 1100204381
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 56 YR
• Patient Sex: Male