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

Model Number	72404281
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Codes	Erosion (1750); Unspecified Infection (1930); Perforation (2001)
Date of Event	04/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had the inflatable penile prosthesis removed three months after the initial implant, due to infection.The cylinder crossed the corporal body of the penis perforating tissue and extruded out of the end of the penis.Additionally, device inflation was not smooth.Following the procedure the patient was stable.There were no further patient complications reported.
Additional Manufacturer Narrative
There was no device available for analysis.The reported patient symptoms are known risk associated with implants of these device as indicated in the instructions for use (ifu).The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.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 had the inflatable penile prosthesis removed three months after the initial implant, due to infection.The cylinder crossed the corporal body of the penis perforating tissue and extruded out of the end of the penis.Additionally, device inflation was not smooth.Following the procedure the patient was stable.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: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 14347174
• Report Number: 2124215-2022-15954
• Device Sequence Number: 20138916
• Product Code: FHW
• UDI-Device Identifier: 00878953003849
• UDI-Public: 00878953003849
• 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: 2022
• 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): 06/16/2022

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: 02/12/2025
• Device Model Number: 72404281
• Device Catalogue Number: 72404281
• Device Lot Number: 1000396658
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2022
• Supplement Date Received by Manufacturer: 05/26/2022
• Initial Report FDA Received Date: 05/10/2022
• Supplement Report FDA Received Date: 06/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2020
• 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: RESERVOIR MODEL #720182-01 LOT #1000525479; RESERVOIR MODEL #720182-01 LOT #1000525479
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 32 YR
• Patient Sex: Male