AMS 700 CX MS PUMP

Additional Manufacturer Narrative

MODEL NUMBER/CATALOG NUMBER: 720185-01. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 1000218295. MODEL/CATALOG DESCRIPTION: RESERVOIR FLAT IZ 100 ML. UNIQUE IDENTIFIER (UDI) #: (B)(4). THE DEVICE IS NOT AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. SPONTANEOUS DEFLATION, MIGRATION, TISSUE DAMAGE AND DISFIGUREMENT ARE ACKNOWLEDGED WITHIN THE INSTRUCTIONS FOR USE (IFU) AND ARE NOT RELATED TO OFF-LABEL USE OR FAILURE TO FOLLOW INSTRUCTIONS. THE REPORTED PATIENT SYMPTOMS OF TISSUE DAMAGE AND DISFIGUREMENT ARE KNOWN RISKS ASSOCIATED WITH THIS DEVICE TYPE AND INDICATED AS SUCH IN THE INSTRUCTIONS FOR USE.

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH A DEVICE THAT WOULD NOT MAINTAIN RIGIDITY SUFFICIENT FOR PENETRATION, WITH THE PATIENT REPORTING THAT THE DEVICE DEFLATED AFTER 5 TO 10 MINUTES OF INTERCOURSE. THE PATIENT SUBSEQUENTLY REPORTED LEFTWARD CURVATURE. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN CONFIRMED CYLINDER CROSSOVER AND NOTED THAT BOTH CYLINDERS WERE LOCATED IN THE DISTAL RIGHT CORPORAL BODY. THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO FURTHER PATIENT COMPLICATIONS.