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

Model Number	72404281
Medical Device Problem Codes	Collapse (1099); Inflation Problem (1310); Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an original inflatable penile prosthesis (ipp) implant procedure, the device was already placed inside the patient and a test was performed.It was noticed that the pump is not completely filled, and it remains dimpled.The physician decided to remove the ipp and implant a new one to complete the procedure.No patient complications were reported.
Event or Problem Description
It was reported that during an original inflatable penile prosthesis (ipp) implant procedure, the device was already placed inside the patient and a test was performed.It was noticed that the pump is not completely filled, and it remains dimpled.The physician decided to remove the ipp and implant a new one to complete the procedure.No patient complications were reported.
Additional Manufacturer Narrative
B2: outcomes related to adverse event: updated.

• 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: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 15704507
• Report Number: 2124215-2022-44341
• Device Sequence Number: 11995048
• Product Code: FHW
• UDI-Device Identifier: 00878953003849
• UDI-Public: 00878953003849
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• 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): 04/28/2023

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 Model Number: 72404281
• Device Catalogue Number: 72404281
• Device Lot Number: 1100048695
• 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: 10/21/2022
• Supplement Date Received by Manufacturer: 02/06/2023
• Initial Report FDA Received Date: 10/31/2022
• Supplement Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2021
• 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: Required Intervention; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Male