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

Model Number	UNK-P-IPP
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: based on the information available, the cause that contributed to the reported device inflation issue could not be established as the product is not available for analysis.Device history record review (dhr): the device history record review (dhr) confirmed that the device met all material, assembly and performance specifications.Device technical analysis: the device was not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation of inflation issues cannot be confirmed.Labeling review: a review of the device instructions for use (ifu) was completed and did not review any evidence of device off-label use or failure to follow instructions.Investigation conclusion: based on this investigation a clear probable cause for the event cannot be established; therefore, the conclusion code of cause not established has been chosen.
Event or Problem Description
It was reported that the patient was scheduled on (b)(6) 2021 to have the inflatable penile prosthesis replaced as after 2 years of implant.The device never seemed to get to 100% hardness and seemed to have lost some length and girth.The entire pump mechanism deflated.
Additional Manufacturer Narrative
Investigation summary: based on the information available, the cause that contributed to the reported device inflation issue could not be established as the product is not available for analysis.Device history record review (dhr): the device history record review (dhr) of manufacturing documentation was not performed as the serial/lot number for this component was not provided.Device technical analysis: the device was not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation of inflation issues cannot be confirmed.Labeling review: a review of the device instructions for use (ifu) was completed and did not review any evidence of device off-label use or failure to follow instructions.Investigation conclusion: based on this investigation a clear probable cause for the event cannot be established; therefore, the conclusion code of cause not established has been chosen.
Event or Problem Description
It was reported that the patient was scheduled on 06apr2021 to have the inflatable penile prosthesis replaced as after 2 years of implant.The device never seemed to get to 100% hardness and seemed to have lost some length and girth.The entire pump mechanism deflated.

• 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
• MDR Report Key: 11585246
• Report Number: 2183959-2021-01158
• Device Sequence Number: 11953906
• Product Code: FHW
• UDI-Device Identifier: 00878953004075
• UDI-Public: 00878953004075
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/20/2024
• Device Model Number: UNK-P-IPP
• Device Catalogue Number: UNK-P-IPP
• Device Lot Number: 1000235143
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/03/2021
• Supplement Date Received by Manufacturer: 04/28/2021
• Initial Report FDA Received Date: 03/29/2021
• Supplement Report FDA Received Date: 04/30/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RTE SNAPCONEMODEL # 72404323LOT # 1000235143
• Patient Age: 53 YR