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

Model Number	72401452
Medical Device Problem Codes	Inflation Problem (1310); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that one of the cylinders of this ambicor penile prosthesis (app) exhibited inflation issues.A surgical procedure was performed, during which the app was removed, and an inflatable penile prosthesis (ipp) was implanted.There were no patient complications reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this ambicor penile prosthesis (app) underwent a thorough analysis.Both cylinders were microscopically inspected and tested for leaks.The first cylinder exhibited wear at fold in its middle and proximal end, along with a leak due to a hole at a corner of a fold and broken fabric threads in the middle of its body.In addition, the first cylinder presented another leak due to a hole in its proximal end, consistent with sharp instrument damage.The second cylinder had wear at fold and broken fabric threads in the middle of its body, along with a bulge in its middle when it was inflated with a syringe.The pump was microscopically inspected, and leak tested.Microscopic evaluation revealed that the kink resistant tubing (krt) was worn to the filament, but no leaks were identified in the component.Based on the information available and analysis results, the leak identified in the first cylinder and the bulge noted in the second cylinder could have caused or contributed to the reported clinical observation of inflation issues.
Event or Problem Description
It was reported that one of the cylinders of this ambicor penile prosthesis (app) exhibited inflation issues.A surgical procedure was performed, during which the app was removed, and an inflatable penile prosthesis (ipp) was implanted.There were no patient complications reported.

• 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
• 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: 20034124
• Report Number: 2124215-2024-52003
• Device Sequence Number: 11525146
• Product Code: FHW
• UDI-Device Identifier: 00878953000961
• UDI-Public: 00878953000961
• 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: 2017
• 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
• Report Date (Section B): 10/23/2024

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 Expiration Date: 12/13/2021
• Device Model Number: 72401452
• Device Catalogue Number: 72401452
• Device Lot Number: 0158550003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2024
• Supplement Date Received by Manufacturer: 10/07/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2016
• 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: UPN: 72404155; RESERVOIR: UPN: 72404155
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown