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

Model Number	72401455
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	04/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this ambicor penile prosthesis (app) exhibited inflation issues.A revision surgery was performed to explant and replace the device.No patient complications were reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, the returned device underwent a thorough analysis.The cylinders were visually and microscopically inspected.Both cylinders had wear at folds in the middle of the cylinder body.The first cylinder had a hole and resultant leak, consistent with sharp instrument damage, in the proximal end.The second cylinder had broken fabric threads from wear in the middle.The second cylinder also bulged when inflated.The pump was visually and microscopically inspected.A hole and resultant leak were found at the strain relief junction.The hole was consistent with sharp instrument damage.Analysis confirmed the reported clinical observations.
Event or Problem Description
It was reported that this ambicor penile prosthesis (app) exhibited inflation issues.A revision surgery was performed to explant and replace the device.No patient complications were 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: 19165890
• Report Number: 2124215-2024-23390
• Device Sequence Number: 7873645
• Product Code: FHW
• UDI-Device Identifier: 00878953000992
• UDI-Public: 00878953000992
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2024

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: 03/17/2025
• Device Model Number: 72401455
• Device Catalogue Number: 72401455
• Device Lot Number: 1000414417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/11/2024
• Supplement Date Received by Manufacturer: 06/07/2024
• Initial Report FDA Received Date: 04/23/2024
• Supplement Report FDA Received Date: 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male