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

Model Number	72404014
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	02/17/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Detailed product information for the reservoir 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.Model number/catalog number: 72404310.Serial number: n/a.Batch/lot number: 1000455064.Model/catalog description: pump ms.Unique identifier (udi) #: (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.Therefore, a conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
It was reported that the patient's inflatable penile prosthesis (ipp) was not functioning properly.A surgical procedure was performed, during which a hole in the left cylinder was identified.The left cylinder and the pump were replaced.No patient complications were reported.
Event or Problem Description
It was reported that the patient's inflatable penile prosthesis (ipp) was not functioning properly.A surgical procedure was performed, during which a hole in the left cylinder was identified.The left cylinder and the pump were replaced.No patient complications were reported.
Additional Manufacturer Narrative
Correction to field b1: adverse event/product problem.Detailed product information for the reservoir 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.Model number/catalog number: 72404310.Serial number: n/a.Batch/lot number: 1000455064.Model/catalog description: pump ms.Unique identifier (udi) #: (b)(4).Upon receipt at our quality assurance laboratory, the return components underwent a thorough analysis.The first cylinder was microscopically inspected and leak tested.Microscopic inspection revealed broken and detached fabric threads, as well as inner tubing damage due to fatigue in the proximal end of the cylinder.Wear was also observed at folds located in the proximal, middle, and distal sections of the cylinder.Additionally, a hole was identified in the outer tube at the proximal end, attributed to fatigue.Leak testing confirmed a leak originating from fatigue in the proximal end of the cylinder.The ms pump was microscopically inspected, leak tested and functionally evaluated.Microscopic examination showed that the pump tubing had been cut down to the pump block; tubing from one cylinder remained attached to that cylinder, while the other two kink resistant tubings were not returned for analysis.The ms pump passed both the leak test and functional testing.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 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 and analysis results, the leak from fatigue identified in the first cylinder could have caused or contributed to the reported clinical observation of cylinder hole/perforated and device mechanical issue.Therefore, a conclusion code of cause traced to component failure was assigned to this investigation.

• Brand Name: AMS 700 CXR
• 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: 24744496
• Report Number: 2124215-2026-17571
• Device Sequence Number: 18471146
• 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: 2021
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2026

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: 03/04/2025
• Device Model Number: 72404014
• Device Catalogue Number: 72404014
• Device Lot Number: 1000407123
• 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: 03/05/2026
• Supplement Date Received by Manufacturer: 05/22/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 06/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2020
• 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: 67 YR
• Patient Sex: Male