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

Model Number	72404230
Medical Device Problem Codes	Inflation Problem (1310); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient could not inflate the inflatable penile prosthesis (ipp) device.A revision surgery has been requested.No further information has been provided.
Additional Manufacturer Narrative
Date of event: unknown, used the first day of the aware month.The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Neither the reported patient symptoms or device performance allegation can be confirmed.Based on the information available, a conclusion code of no problem detected was assigned to this investigation.
Additional Manufacturer Narrative
Investigation summary: with all the available information, boston scientific concludes that the cylinder bulge and the pump failure to have the valve in deactive state could affect the functionality of the device.Product analysis confirmed a device issue.Device history record review: the device history record (dhr) confirmed that the device met all material, assembly and performance specifications.Device technical analysis: the cylinders were visually inspected, leak tested, pressure tested and examined using a microscope.Cylinder 1 has broken fabric threads with bulge when inflated with syringe in the distal cylinder body.No leaks were found.Cylinder 2 passed all tests performed.The pump was examined and tested.No visual damages were found upon inspection however; the pump failed the valve deactive state test.The spherical reservoir was inspected and no visual damages were found upon inspection.The reservoir passed all tests performed.The product analysis confirmed the reported event.Labeling review: a review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.Investigation conclusion: based on the information available, a conclusion code of caused traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that the patient could not inflate the inflatable penile prosthesis (ipp) device.A replacement surgery was performed.No further information has been provided.
Additional Manufacturer Narrative
Investigation summary: with all the available information, boston scientific concludes that the cylinder bulge and the pump not passing deactivate state testing could have caused the clinical observations.Device history record (dhr) review: dhr review confirmed that the device met all material, assembly and performance specifications.Device technical analysis: the cylinders were visually and microscopically inspected, and underwent leak and pressure testing.A bulge was found in the distal body one cylinder upon inflation with a syringe.The other cylinder passed all testing.The pump was examined and tested.No visual damages were found upon inspection however; the pump did not pass the valve deactivate state test.The reservoir was inspected and no visual damages were found upon inspection.The reservoir passed all tests performed.Product analyses of the cylinder and pump confirmed the reported event.Labeling review: a review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.Investigation conclusion: based on the information available, a conclusion code of caused traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that the patient could not inflate the inflatable penile prosthesis (ipp) device.A replacement surgery was performed.No 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 ; 4089353452
• MDR Report Key: 12918902
• Report Number: 2124215-2021-37172
• Device Sequence Number: 20245133
• Product Code: FHW
• UDI-Device Identifier: 00878953003436
• UDI-Public: 00878953003436
• Combination Product (Y/N): Y
• Initial Reporter Country: TU
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/29/2022

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: 07/08/2022
• Device Model Number: 72404230
• Device Catalogue Number: 72404230
• Device Lot Number: 1000434005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2021
• Supplement Date Received by Manufacturer: 03/01/2022; 03/11/2022
• Initial Report FDA Received Date: 12/02/2021
• Supplement Report FDA Received Date: 03/04/2022; 03/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: RESERVOIR 724041551000560788; RESERVOIR 724041551000560788; RESERVOIR 724041551000560788; RTE SNAPCONE 724043211000301694; RTE SNAPCONE 724043211000301694; RTE SNAPCONE 724043211000301694
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male