AMS 700 CX MS PUMP
Received Jul 6, 2026 · Event occurred Jun 11, 2026
Report 2124215-2026-36023 · MDR key 25721918
Device
Generic name
Prosthesis, Penis, Inflatable
Manufacturer
Boston Scientific CorporationModel number
72404236Catalog number
72404236
Lot number
933557005
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Scar Tissue
Narrative
Additional Manufacturer Narrative
MODEL NUMBER/CATALOG NUMBER: 720185-01. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 126492019. MODEL/CATALOG DESCRIPTION: RESERVOIR FLAT IZ 100 ML. UNIQUE IDENTIFIER (UDI) #: (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WOULD INFLATE; HOWEVER, IT EXPANDED LATERALLY RATHER THAN LONGITUDINALLY. A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH THE IPP WAS REMOVED, AND SIGNIFICANT AMOUNT OF TISSUE WAS ALSO REMOVED FROM THE CORPORA. AFTER THE REMOVAL, THE IPP WAS TESTED AND WAS FOUND TO BE FULLY FUNCTIONAL. THE SUSPECTED CAUSE OF THE INCORRECT INFLATION WAS THE SIGNIFICANT AMOUNT OF TISSUE FOUND. AS A RESULT, A TACTRA WAS IMPLANTED TO ALLOW THE PATIENT TO HEAL. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.