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

Model Number	72404303
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932); Pain (1994)
Date of Event	04/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with an inflatable penile prosthesis (ipp) presented with prosthetic infection.Due to the pain from the infection and the difficulty with pressing the pump, the patient was unable to cycle and inflate the device.The patient underwent a surgical procedure to explant the ipp and implant a new tactra malleable penile prosthesis.No further patient complications were reported.
Event or Problem Description
It was reported that the patient with an inflatable penile prosthesis (ipp) presented with pain, a prosthetic infection, and inflammation.Due to the pain from the infection and the difficulty with pressing the pump, the patient was unable to cycle and inflate the device.The patient underwent a surgical procedure to explant the ipp and implant a new tactra malleable penile prosthesis.No further patient complications were reported.
Additional Manufacturer Narrative
Correction made to h6 patient codes.
Additional Manufacturer Narrative
Based on the information available, the product analysis of the inflatable penile prosthesis (ipp) was unable to be performed because the device was not returned to boston scientific.Review of the manufacturing documentation did not find any evidence that the device failed to meet product specifications prior to shipment.The reported pain, infection, and difficulty cycling the device are anticipated in nature and documented in the instructions for use and hazard analysis.Although the cause of the event was not established, review of the labeling documentation did confirm there was no evidence the device was handled improperly, and the events are documented as adverse events of the surgical implant of the device.The labelling documentation does include pain, infection, difficulty with inflation, and inflammation; therefore, the reported events are known inherent risks with ipp.
Event or Problem Description
It was reported that the patient with an inflatable penile prosthesis (ipp) presented with pain, a prosthetic infection, and inflammation.Due to the pain from the infection and the difficulty with pressing the pump, the patient was unable to cycle and inflate the device.The patient underwent a surgical procedure to explant the ipp and implant a new tactra malleable penile prosthesis.No further patient complications were 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: 14459419
• Report Number: 2124215-2022-17496
• Device Sequence Number: 19959922
• Product Code: FHW
• UDI-Device Identifier: 00878953005744
• UDI-Public: 00878953005744
• 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
• 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,Followup
• Report Date (Section B): 08/11/2022

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/08/2026
• Device Model Number: 72404303
• Device Catalogue Number: 72404303
• Device Lot Number: 1000537216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/03/2022
• Supplement Date Received by Manufacturer: 05/27/2022; 07/22/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 06/14/2022; 08/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CYLINDER: UPN: 72404303 LOT#: 1000537216; CYLINDER: UPN: 72404303 LOT#: 1000537216; CYLINDER: UPN: 72404303 LOT#: 1000537216; RESERVOIR: UPN: 720185-01 LOT#:1000577738; RESERVOIR: UPN: 720185-01 LOT#:1000577738; RESERVOIR: UPN: 720185-01 LOT#:1000577738
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male