AMS 700 LGX
Received Jun 11, 2025 · Event occurred Apr 28, 2025
Report 2124215-2025-37824 · MDR key 22186697
Device
Generic name
Prosthesis, Penis, Inflatable
Manufacturer
Boston Scientific CorporationModel number
72404293Catalog number
72404293
Lot number
1000579988
Product problems
- Mechanical Problem
- Material Puncture/Hole
- Adverse Event Without Identified Device or Use Problem
- Mechanical Problem
- Nonstandard Device
- Material Puncture/Hole
- Adverse Event Without Identified Device or Use Problem
Patient
59 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
UDI FIELD (D4) CONCOMITANT PRODUCT UDI FOR PUMP IS (B)(4). UDI FIELD (D4) CONCOMITANT PRODUCT UDI FOR RESERVOIR IS (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS PRESENTED WITH A NONFUNCTIONING DEVICE. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN CONFIRMED A CRACK IN THE CYLINDER CONNECTING TUBE. THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.
Additional Manufacturer Narrative
UDI FIELD (D4) CONCOMITANT PRODUCT UDI FOR PUMP IS (B)(4). UDI FIELD (D4) CONCOMITANT PRODUCT UDI FOR RESERVOIR IS (B)(4). UPON RECEIPT AT THE QUALITY ASSURANCE LABORATORY, THE RETURNED COMPONENTS UNDERWENT A COMPREHENSIVE EVALUATION. MICROSCOPE INSPECTION OF THE FIRST CYLINDER REVEALED A HOLE IN THE PROXIMAL END AND OUTER TUBE DUE TO SHARP INSTRUMENT DAMAGE AND KRT (KINK RESISTANT TUBING) WEAR, ALSO WITH WEAR AT THE FOLD IN THE PROXIMAL END, NOT PASSING THE MICROSCOPE INSPECTION. LEAKAGE TESTING SHOWED THE TUBING LEAKED DUE TO SHARP INSTRUMENT DAMAGE IN THE PROXIMAL END, ALSO NOT PASSING THE TEST. MICROSCOPE INSPECTION OF THE SECOND CYLINDER REVEALED WEAR AT THE FOLD IN BOTH PROXIMAL AND DISTAL ENDS, NOT PASSING THE TEST, WHILE LEAKAGE TESTING PASSED THE TEST. MICROSCOPE INSPECTION OF THE PUMP SHOWED NO DAMAGE; IT PASSED VISUAL INSPECTION AND LEAK TESTING; HOWEVER, THE COMPONENT DID NOT PASS ACTIVATION TEST DURING FUNCTIONAL EVALUATION. MICROSCOPE INSPECTION OF THE RESERVOIR PASSED VISUAL INSPECTION WITH NO DAMAGE FOUND, AND LEAKAGE TESTING PASSED. BASED ON THE AVAILABLE INFORMATION AND ANALYSIS RESULTS, THE SHARP INSTRUMENT DAMAGE FOUND ON THE DEVICE IS CONSIDERED A SECONDARY FAILURE. THE ALLEGATIONS OF MECHANICAL ISSUE AND HOLE/PERFORATION COULD NOT BE CONFIRMED; HOWEVER, THE PUMP NOT PASSING FUNCTIONAL INSPECTION COULD AFFECT PRODUCT PERFORMANCE. THEREFORE, THE CONCLUSION CODE OF CAUSE TRACED TO COMPONENT FAILURE WAS ASSIGNED TO THIS INVESTIGATION.
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS IPP PRESENTED WITH A NONFUNCTIONING DEVICE. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN CONFIRMED A CRACK IN THE CYLINDER CONNECTING TUBE. THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.