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

Model Number	72401450
Medical Device Problem Codes	Inflation Problem (1310); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a physician requested a revision for an ambicor penile prosthesis (app) due to the device not inflating.There were no patient symptoms or adverse events.It was unknown whether there were any specific device malfunctions causing the device not to inflate.The surgical procedure had not been scheduled yet.
Additional Manufacturer Narrative
Investigation summary: based on the information available, the cause that contributed to the reported device not inflating cannot be established as the product is not available for analysis.Dhr review: the device history record (dhr) confirmed that the device met all material, assembly and performance specifications.Technical analysis: the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Labeling review: a review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.Investigation conclusion: based on the information available, a conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
It was reported that a physician requested a revision for an ambicor penile prosthesis (app) due to the device not inflating.There were no patient symptoms or adverse events.It was unknown whether there were any specific device malfunctions causing the device not to inflate.The surgical procedure had not been scheduled yet.
Additional Manufacturer Narrative
Investigation summary: with all the available information, boston scientific concludes that product analysis confirmed the reported allegation of inflation issues as a block was identified on the ambicor pump.Dhr review: the device history record (dhr) confirmed that the device met all material, assembly and performance specifications.Technical analysis: upon receipt at our post market quality assurance laboratory, this ambicor penile prosthesis (app) was thoroughly analyzed.Visual and microscopical inspection of the app identified wear at fold in the cylinder bodies; however, there were no leaks found.Functional testing of the device identified hat the pump was difficult to deflate/inflate as the fluid was not flowing from the pump.The identified blocking could affect the functionality of the device, leading to the reported inflation issues.Labeling review: a review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.Investigation conclusion: based on the information available, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that a physician requested a revision for an ambicor penile prosthesis (app) due to the device not inflating.There were no patient symptoms or adverse events.It was unknown whether there were any specific device malfunctions causing the device not to inflate.A surgical procedure was performed in which the device was explanted.The patient was in good condition following the intervention.

• Brand Name: AMS AMBICOR 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: 11887031
• Report Number: 2124215-2021-14925
• Device Sequence Number: 14389765
• Product Code: FHW
• UDI-Device Identifier: 00878953000947
• UDI-Public: 00878953000947
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/16/2021

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: 04/12/2015
• Device Model Number: 72401450
• Device Catalogue Number: 72401450
• Device Lot Number: 647005004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2021
• Initial Date Received by Manufacturer: 05/06/2021
• Supplement Date Received by Manufacturer: 06/17/2021; 08/26/2021
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 07/12/2021; 09/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention