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

Model Number	72404283
Medical Device Problem Codes	Degraded (1153); Inflation Problem (1310); Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)
Date of Event	09/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Model number: 720182-01.Lot number: 839112010.Model description: reservoir flat 100 ml.
Event or Problem Description
It was reported that the inflatable penile prosthesis (ipp) device is going to be revised due to a malfunction, bulging on the left side of the penis, and an inability to inflate the cylinders."patient complained of malfunction of the penile prosthesis and bulging on the left side of the penis.When being examined, i [doctor] really confirmed the impossibility of filling the cylinders and observed the bulging of the left cavernous body.The patient implanted the first inflatable penile prosthesis ams 700 approximately 15 years ago and this period is the third time that the same defect occurs.Therefore, i [doctor] request the use of the warranty to perform replacement and replantation of the penile prosthesis as soon as possible." further information was requested and not yet received.Should additional relevant details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the inflatable penile prosthesis (ipp) device is going to be revised due to an unspecified issue, bulging on the left side of the penis, and an inability to inflate the cylinders.The patient stated the prosthesis was not working as expected and bulging on the left side of his penis.Upon examination, the physician confirmed the impossibility of filling the cylinders and observed bulging of the left cavernous body.The physician has requested warranty approval to replace the device.The explanted device was later returned indicting the patient underwent a revision surgery.
Additional Manufacturer Narrative
Investigation summary: with the available information boston scientific concluded that the reported inflation issues and mechanical issues were confirmed as analysis found bulging with broken fabric threads in cylinder 1 and the pump required more than 8lbs of force to activate.These malfunctions could impact the functionality of the device.Device history record (dhr) review: the device history record (dhr) confirmed that the device met all material, assembly and performance specifications.Device technical analysis: the ams 700 cylinders, pump and reservoir were returned and upon receipt at our post market quality assurance laboratory, this device was thoroughly analyzed.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.Cylinder 1 had a bulge with broken fabric threads in the proximal cylinder body when inflated with syringe.The cylinder was not pressure test due to that bulge was identified.Cylinder 2 passed the leak and pressure testing.The ams700 momentary squeeze (ms) pump was leak tested, visually inspected, examined using a microscope, and functionally tested.No visual damages were found upon inspection.The pump was functionally tested and did not pass the 8lb.Activation test.The pump required more than 8lbs.Of force to activate.The ams700 ipp flat reservoir was visually inspected, leak tested and examined using a microscope.The reservoir had wear at a fold in the reservoir shell; no leaks were found.This wear would not affect the functionality of device.Product analysis concluded the pump activation issues and the cylinder bulge could affect the functionality of the device as the reported inflation and mechanic issues.Product analysis confirmed the reported events.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 cause traced component failure was assigned to this investigation.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS
• 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: 9186437
• Report Number: 2183959-2019-66810
• Device Sequence Number: 2362582
• Product Code: FHW
• UDI-Device Identifier: 00878953003863
• UDI-Public: 00878953003863
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2022

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: 10/16/2019
• Device Model Number: 72404283
• Device Catalogue Number: 72404283
• Device Lot Number: 0902744002
• 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: 09/19/2019
• Supplement Date Received by Manufacturer: 03/14/2022
• Initial Report FDA Received Date: 10/14/2019
• Supplement Report FDA Received Date: 04/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2014
• 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 UPN: 720182-01LOT #: 839112010
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male