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

Model Number	72404301
Medical Device Problem Codes	Inflation Problem (1310); Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	05/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was implanted with an inflatable penile prosthesis device.The patient had hematoma post procedure, but the patient was recovered one month after the implant surgery.There was no device performance allegation.There were no further patient complications.
Additional Manufacturer Narrative
There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient symptoms are a known risk associated with implant of these devices as indicated in the instructions for use.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
Event or Problem Description
It was reported that the patient was implanted with an inflatable penile prosthesis device.The patient had hematoma post procedure, but the patient was recovered one month after the implant surgery.There was no device performance allegation.There were no further patient complications.
Additional Manufacturer Narrative
H6.Evaluation method codes updated.There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient symptoms are a known risk associated with implant of these devices as indicated in the instructions for use.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
Event or Problem Description
It was reported that the patient was implanted with an inflatable penile prosthesis device.The patient had hematoma post procedure, but the patient was recovered one month after the implant surgery.There was no device performance allegation.There were no further patient complications.
Event or Problem Description
It was reported that the patient was implanted with an inflatable penile prosthesis device.The patient had hematoma post procedure, but the patient was recovered one month after the implant surgery.The patient noted two months post procedure that the implantation length did not meet his expectations.The patient further reported that the device could not be inflated normally.After repeated debugging by the physician and the magnetic resonance imaging, the physician preliminarily determined that the pump was faulty.No surgical intervention has been performed as of yet for the pump issue.

• 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
• MDR Report Key: 17575364
• Report Number: 2124215-2023-44568
• Device Sequence Number: 8268144
• Product Code: FHW
• UDI-Device Identifier: 00878953005720
• UDI-Public: 00878953005720
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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,Followup,Followup
• Report Date (Section B): 04/01/2024

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 Model Number: 72404301
• Device Catalogue Number: 72404301
• Device Lot Number: 1100107119
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/31/2023
• Supplement Date Received by Manufacturer: 08/21/2023; 09/18/2023; 03/22/2024
• Initial Report FDA Received Date: 08/18/2023
• Supplement Report FDA Received Date: 09/18/2023; 09/19/2023; 04/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2022
• 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: RESERVOIRUPN: 720182-01 LOT: 1100127600; RESERVOIRUPN: 720182-01LOT: 1100127600; RESERVOIRUPN: 720182-01LOT: 1100127600; RESERVOIRUPN: 720182-01LOT: 1100127600
• Outcome Attributed to Adverse Event: Other
• Patient Age: 26 YR
• Patient Sex: Male