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

Model Number	72404011
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	04/24/2024
Type of Reportable Event	Serious Injury
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 device as indicated in the instructions for use (ifu).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 cylinder of this inflatable penile prosthesis (ipp) perforated the distal end of the patient's penis.A surgical procedure was performed to remove the cylinder.There were no further patient complications reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, the returned component underwent a thorough analysis.The cylinder was microscopically inspected, and leak tested.Holes in the middle of the component that led to fluid leak were noted, consistent with sharp instrument damage.The reported patient symptom of perforation and the device migration are a known risk associated with implant of these device as indicated in the instructions for use (ifu).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 cylinder of this inflatable penile prosthesis (ipp) perforated the distal end of the patient's penis.A surgical procedure was performed to remove the cylinder.There were no further patient complications reported.
Additional Manufacturer Narrative
Additional information updated: b5: describe event/problem.Upon receipt at our quality assurance laboratory, the returned component underwent a thorough analysis.The cylinder was microscopically inspected, and leak tested.Holes in the middle of the component that led to fluid leak were noted, consistent with sharp instrument damage.The reported patient symptom of perforation and device migration are a known risk associated with implant of these device as indicated in the instructions for use (ifu).
Event or Problem Description
It was reported that the cylinder of this inflatable penile prosthesis (ipp) perforated the distal end of the patient's penis.A surgical procedure was performed to remove the cylinder, and four months later, the patient underwent a reimplant surgery.There were no further patient complications reported.

• 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: 19310487
• Report Number: 2124215-2024-29078
• Device Sequence Number: 15181140
• Product Code: FHW
• UDI-Device Identifier: 00878953002682
• UDI-Public: 00878953002682
• 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: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/26/2024

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: 72404011
• Device Catalogue Number: 72404011
• Device Lot Number: 1100188578
• 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: 04/26/2024
• Supplement Date Received by Manufacturer: 06/18/2024; 09/06/2024
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 06/21/2024; 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2022
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 75 KG