MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE; DEVICE IMPOTENCE MECHANICAL/HYDRAULIC

Model Number	72404262
Medical Device Problem Codes	Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a surgical procedure to explant this inflatable penile prosthesis (ipp) due to the left cylinder pushing laterally on the skin in addition to pain in the glans at the cylinder tip.The existing device was removed and replaced with a new ipp.No further patient complications were reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, the ams700 inflatable penile prosthesis (ipp) was visually inspected, leak tested and examined using a microscope.Both cylinders had wear at folds in the middle and proximal cylinder bodies and the kink resistant tubing (krt) of both cylinders was worn down to the filament.No leaks were found.Inspection of the momentary squeeze (ms) pump noted the krt was worn down to the filament.Again, no leaks were identified.The pump krt with window quick connector was trimmed down to the appropriate length prior to functional testing.The pump did not pass the inflation test.Product analysis concluded these inflation issues could affect the functionality of the device as reported mechanical issues.Product analysis confirmed pump malfunction but was unable to confirm the reported event related to the pain.
Event or Problem Description
It was reported that the patient underwent a surgical procedure to explant this inflatable penile prosthesis (ipp) due to the left cylinder pushing laterally on the skin in addition to pain in the glans at the cylinder tip.The existing device was removed and replaced with a new ipp.No further patient complications were reported.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
• Common Device Name: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• 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: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 16016928
• Report Number: 2124215-2022-53873
• Device Sequence Number: 17827040
• Product Code: FHW
• UDI-Device Identifier: 00878953003702
• UDI-Public: 00878953003702
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2023

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: 01/12/2017
• Device Model Number: 72404262
• Device Catalogue Number: 72404262
• Device Lot Number: 915942005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2022
• Supplement Date Received by Manufacturer: 01/30/2023
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 01/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2015
• 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: 73 YR
• Patient Sex: Unknown