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

Model Number	72404283
Medical Device Problem Codes	Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient is requesting a revision of an inflatable penile prosthesis(ipp) due to an aneurysm in the left cylinder associated with an increase in the amount of pressure the pump requires to inflate the prosthesis.Imaging confirmed the aneurysm.A patient outcome of stable was reported.
Event or Problem Description
It was reported that the patient had a revision of this inflatable penile prosthesis (ipp) due to an aneurysm in the left cylinder associated with an increase in the amount of pressure the pump requires to inflate the prosthesis.Imaging confirmed the aneurysm.A patient outcome of stable was reported.
Additional Manufacturer Narrative
Upon receipt of the product at our quality assurance laboratory, the returned ipp device underwent a thorough analysis and product analysis was unable to confirm the reported allegation.The ams 700 inflatable penile prosthesis (ipp) cylinders were visually inspected, leak/pressure tested, and examined using a microscope.The cylinder 1 tubing was detached on the medial with only a part of the outer tubing still attaching the cylinder body together, and therefore, cylinder 1 was not leak tested.Cylinder 2 had wear at a fold on the proximal and by the distal of the body.The cylinder 2 was leak tested and passed within specification.The ams 700 momentary squeeze (ms) pump was visually inspected, leak tested, examined using the microscope, and functionally tested.Under microscope examination, contamination (tissue) was found within the pump in which the pump was not functionally tested.The analysis was unable to identify the reported event of bulged due to the detachment of the cylinder 1 tubing and cylinder 2 had no leak or no abnormality to the device when inspected.

• 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: 11852096
• Report Number: 2124215-2021-14336
• Device Sequence Number: 11569063
• 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,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2022

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: 06/17/2018
• Device Model Number: 72404283
• Device Catalogue Number: 72404283
• Device Lot Number: 835273001
• 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: 04/30/2021
• Supplement Date Received by Manufacturer: 12/02/2022
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 61 YR
• Patient Sex: Male