AMS 700 LGX
Received Sep 23, 2025 · Event occurred Aug 14, 2025
Report 2124215-2025-66712 · MDR key 23127809
Device
Generic name
Prosthesis, Penis, Inflatable
Manufacturer
Boston Scientific CorporationModel number
72404293Catalog number
72404293
Lot number
0135694004
Product problems
- Mechanical Problem
- Nonstandard Device
- Material Puncture/Hole
- Mechanical Problem
- Nonstandard Device
- Material Puncture/Hole
Patient
66 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) VISITED THE HOSPITAL BECAUSE THE PRODUCT DID NOT FUNCTION PROPERLY. TWO WEEKS LATER UPON INSPECTION, IT WAS CONFIRMED THAT THE LEFT CYLINDER HAD A HOLE, SO THE LEFT CYLINDER AND THE PUMP WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS REPORTED.
Additional Manufacturer Narrative
D4. CONCOMITANT PRODUCT UDI FOR PUMP IS (B)(4) AND FOR RESERVOIR IS (B)(4). G4: PMA/510(K) # FIELD ON 3500A FORM IS N970012, P000053 - REPORTED HERE AS PMA # EXCEEDED CHARACTER LIMIT FOR DESIGNATED FIELD. UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY, THIS INFLATABLE PENILE PROSTHESIS (IPP) CYLINDER AND PUMP UNDERWENT A THOROUGH ANALYSIS. THE PUMP WAS MICROSCOPICALLY INSPECTED, FUNCTIONALLY AND LEAK TESTED. UNDER MICROSCOPE OBSERVATION, CONTAMINATION (BODILY FLUID) WAS FOUND WITHIN THE MS PUMP. AS A RESULT, THE FUNCTIONAL TEST WAS NOT PERFORMED. THE PUMP TUBING WAS CUT DOWN TO THE PUMP BLOCK; THE TUBING WAS RETURNED ATTACHED TO THE CYLINDERS. NO LEAKS WERE IDENTIFIED. THE CYLINDER WAS MICROSCOPICALLY INSPECTED, AND LEAK TESTED. THE MICROSCOPE TEST FOUND THAT THE CYLINDER HAD AT CORNER OF A FOLD IN THE PROXIMAL END OF THE CYLINDER AND HAD WEAR AT FOLD IN THE PROXIMAL END AND DISTAL END OF THE CYLINDER. THE CYLINDER DID NOT PASS THE LEAK TEST. BASED ON THE INFORMATION AVAILABLE AND ANALYSIS RESULTS, THE HOLE/LEAK AT THE CORNER OF A FOLD IN THE FIRST CYLINDER CONFIRMED THE REPORTED CLINICAL OBSERVATION OF DEVICE- MECHANICAL ISSUE AND CYLINDER - HOLE/PERFORATED.
Additional Manufacturer Narrative
D4. CONCOMITANT PRODUCT UDI FOR PUMP IS (B)(4) AND FOR RESERVOIR IS (B)(4). G4: PMA/510(K) # FIELD ON 3500A FORM IS N970012, P000053 - REPORTED HERE AS PMA # EXCEEDED CHARACTER LIMIT FOR DESIGNATED FIELD.
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) VISITED THE HOSPITAL BECAUSE THE PRODUCT DID NOT FUNCTION PROPERLY. TWO WEEKS LATER UPON INSPECTION, IT WAS CONFIRMED THAT THE LEFT CYLINDER HAD A HOLE, SO THE LEFT CYLINDER AND THE PUMP WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS REPORTED.