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

Model Number	72404264
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504); Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Code	Erosion (1750)
Date of Event	10/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Based on the information available, the cause that contributed to the reported event cannot be established; a conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
It was reported that the patient the patient had the inflatable penile prosthesis pump and cylinders removed as the cylinder herniated out of the left corpora.The cylinders rubbed against each other and formed a small hole that led to a fluid leak.New inflatable penile prosthesis pump and cylinders components were implanted.The patient was expected to fully recover.
Event or Problem Description
It was reported that the patient the patient had the inflatable penile prosthesis pump and cylinders removed as the cylinder herniated out of the left corpora.The cylinders rubbed against each other and formed a small hole that led to a fluid leak.New inflatable penile prosthesis pump and cylinders components were implanted.The patient was expected to fully recover.
Additional Manufacturer Narrative
Investigation summary: with all the available information, boston scientific concludes, based on analysis results, the cause that contributed to the fluid lead was confirmed as a hole resulting in fluid leak would lead to a limited device function.Product analysis was unable to confirm the migration and extrusion.Device history record review (dhr): the device history record review (dhr) confirmed that the device met all material, assembly and performance specifications.The adverse event of device has a fluid leak leading to limited device function and migration and extrusion are known as of a risk of the device and is included in hazard analysis.Device technical analysis: upon receipt at our post market quality assurance laboratory, this device was thoroughly analyzed.The ams700 momentary squeeze (ms) pump was leak tested, visually inspected, examined using a microscope, and functionally tested.The pump kink resistant tubing (krt) was worn down to the filament.No leaks were found.The pump was functionally tested and failed deflation test (2).The ams700 ipp cylinders were visually inspected, leak tested, pressure tested and examined using a microscope.Both cylinders had wear at folds in the cylinder bodies and in the proximal cylinder bodies.The krt of both cylinders were worn down to the filament.Cylinder 1 had holes in the outer tube in the proximal cylinder body.Broken fabric threads and a leak were identified.Cylinder 1 was not pressure tested due to the leak that was identified.Cylinder 2 passed all tests performed.Product analysis confirmed the reported allegation related to hole/perforation and fluid leak but unable to confirm the migration and extrusion.Labeling review: a labeling review found no evidence of device off-label use or failure to follow instructions.Device has a fluid leak leading to limited device function and migration and extrusion are included in the product labeling.Investigation conclusion: based on this investigation a clear probable cause for the event was established; therefore, the conclusion code of cause traced to component failure was chosen, based on the failure with the cylinder that a fluid leak was identified.

• 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 ; 4089353452
• MDR Report Key: 12729704
• Report Number: 2124215-2021-33605
• Device Sequence Number: 11132803
• Product Code: FHW
• UDI-Device Identifier: 00878953003726
• UDI-Public: 00878953003726
• Combination Product (Y/N): Y
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2021

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: 09/21/2019
• Device Model Number: 72404264
• Device Catalogue Number: 72404264
• Device Lot Number: 0187824003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/20/2021
• Supplement Date Received by Manufacturer: 11/08/2021
• Initial Report FDA Received Date: 11/01/2021
• Supplement Report FDA Received Date: 11/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2017
• 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: Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male