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

Model Number	72404230
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation summary: with all of the available information, boston scientific concludes that the reported pump malfunction was not confirmed as analysis visual and functional testing did not identify a pump malfunction.However, analysis identified the kink resistant tubing (krt) was worn to the filament, and both cylinders had a fold on the cylinder body and a leak was identified on one of the cylinders.Technical analysis: the product was returned for analysis to our post market quality assurance laboratory.Visual examination identified the kink resistant tubing (krt) was fatigued and worn to the filament with no leaks present.One of the cylinders had a hole proximal cylinder body with visible fabric threads.The other cylinder also had a fold in the cylinder body.Functional testing of the second cylinder did not identify a fluid leak, the first cylinder was not functional testing as the visual inspection identified a hole causing fluid loss.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.Dhr review: the device history record (dhr) confirmed that the device met all material, assembly and performance specifications.Investigation conclusion: based on the information available, a conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
It was reported that the patient underwent a surgical procedure to revise this inflatable penile prosthesis (ipp) due to the pump not working.The ipp cylinder, pump, and reservoir was explanted and replaced with a new ipp cylinder, pump, and reservoir.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
• Common Device Name: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 11735604
• Report Number: 2124215-2021-10560
• Device Sequence Number: 3029290
• Product Code: FHW
• UDI-Device Identifier: 00878953003436
• UDI-Public: 00878953003436
• Combination Product (Y/N): Y
• Initial Reporter Country: RO
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/27/2021

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: 12/16/2015
• Device Model Number: 72404230
• Device Catalogue Number: 72404230
• Device Lot Number: 862553001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/02/2021
• Initial Report FDA Received Date: 04/27/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 56 YR