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	04/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) went to the hospital because the product was not functioning properly.Two weeks later upon inspection, it was confirmed that the cylinder had a hole, so all components were removed and replaced.No patient complications were reported.
Additional Manufacturer Narrative
Model number/catalog number: 0183420010.Serial number: n/a.Batch/lot number: 72404310.Model/catalog description: pump ms.Unique identifier (udi) #: (b)(4).Model number/catalog number: 0190538014.Serial number: n/a.Batch/lot number: 72018201.Model/catalog description: reservoir flat 100 ml.Unique identifier (udi) #: (b)(4).Upon receipt at the quality assurance laboratory, the returned components underwent a thorough analysis.The first cylinder and its associated kink resistant tubing (krt) were microscopically inspected and leak tested.Microscopic examination revealed a hole in the first cylinder krt caused by sharp instrument damage.A hole was also identified in the middle section of the first cylinder, consistent with sharp instrument damage.In addition, wear was observed at the fold locations in both the proximal end and the middle section of the first cylinder.Leak testing confirmed leakage from the first cylinder krt due to the sharp instrument damage.The second cylinder was also subjected to microscopic inspection and leak testing.Microscopic examination revealed wear at the fold locations in the proximal end and middle section of the second cylinder.The second cylinder successfully passed the leak test, with no leakage detected.The reservoir was microscopically inspected and leak tested.Microscopic examination revealed wear at a fold in the reservoir shell.The reservoir successfully passed the leak test, with no leakage detected.Visual inspection of the 1 cm rear tip extender (rte) was performed.No damage or abnormalities were observed.The pump was microscopically inspected and subjected to leak testing.Microscopic examination revealed contamination (bodily fluid) within the pump.As a result, functional testing could not be performed.Scale buildup was observed within the pump block.The pump successfully passed the leak test, with no leakage detected.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications prior to distribution.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 device has a fluid leak and mechanical malfunction (leaks, incomplete inflation/ deflation, kinking) were 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 the cause that contributed to the reported event cannot be established.Therefore, a conclusion code of cause not established was assigned to this investigation.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 ((b)(4)) 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: 50893171
• Report Number: 2124215-2026-51089
• Device Sequence Number: 5829276
• Product Code: JCW
• UDI-Device Identifier: 00878953003801
• UDI-Public: (01)00878953003801(17)221204(10)1000009454
• 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: 2018
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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: 12/04/2022
• Device Model Number: 72404273
• Device Catalogue Number: 72404273
• Device Lot Number: 1000009454
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/17/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2017
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Male