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

Model Number	72404280
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the pump of this inflatable penile prothesis was tested by the physician and found to lock during activation and deactivation.A revision procedure was scheduled as the device is not usable.No patient complications were reported.
Event or Problem Description
It was reported the pump of this inflatable penile prothesis was tested by the physician and found to lock during activation and deactivation.The patient underwent a surgical procedure in which the device was explanted.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this product was thoroughly analyzed.Visual examination identified that one of the cylinders had a hole at the distal end and at the front tip, as well as leaks; the holes and leaks were consistent with sharp instrument.The other cylinder also had a hole at the middle, with broken fabric threads and a leak, also consistent with sharp instrument damage.Based on the information available, the most probable cause of the reported allegation cannot be established.

• 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 4089353452
• MDR Report Key: 12783984
• Report Number: 2124215-2021-34909
• Device Sequence Number: 4815837
• Product Code: FHW
• UDI-Device Identifier: 00878953003832
• UDI-Public: 00878953003832
• 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: 2021
• 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): 03/15/2024

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: 02/28/2022
• Device Model Number: 72404280
• Device Catalogue Number: 72404280
• Device Lot Number: 0164369005
• 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: 10/28/2021
• Supplement Date Received by Manufacturer: 02/19/2024
• Initial Report FDA Received Date: 11/09/2021
• Supplement Report FDA Received Date: 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2017
• 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: 52 YR
• Patient Sex: Male