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

Model Number	72404239
Medical Device Problem Codes	Inflation Problem (1310); Mechanical Problem (1384); Material Puncture/Hole (1504); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Adhesion(s) (1695)
Date of Event	09/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) was not working properly due to inflation issues.A surgical procedure was performed, during which it was noted that the cylinder was shredded and stuck in the corpora.Cylinders and pump were removed and replaced, while the existing reservoir was drained and retained, and a new one was added to the system.There were no patient complications reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, the returned components underwent a thorough analysis.Both cylinders were microscopically inspected and tested for leaks.The first cylinder exhibited broken fabric threads in the middle of its body, along with multiple twisted folds in its proximal and distal end.In addition, the first cylinder had its outer tubing twisted and completely separated from the cylinder body, resulting in fluid loss.The second cylinder presented its outer tubing twisted in the proximal and distal end, along with a total separation of it in the distal end.Additionally, multiple twisted folds were noted in its distal end, and a hole that led to a leak in the kink resistant tubing (krt) consistent with sharp instrument damage was also identified.The pump was microscopically inspected and tested for leaks.It was not functionally tested due to bodily fluid contamination identified within the component.Microscopic evaluation revealed that its krt was worn to the filament, and a hole and a leak in its krt was also noted.Based on the information available and analysis results, the leaks identified in the first cylinder and pump krt could have caused or contributed to the reported clinical observations.
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) was not working properly due to inflation issues.A surgical procedure was performed, during which it was noted that the cylinder was shredded and stuck in the corpora.Cylinders and pump were removed and replaced, while the existing reservoir was drained and retained, and a new one was added to the system.There were no patient complications reported.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
• 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: 20427208
• Report Number: 2124215-2024-63534
• Device Sequence Number: 20958907
• Product Code: FHW
• UDI-Device Identifier: 00878953003528
• UDI-Public: 00878953003528
• Combination Product (Y/N): Y
• Initial Reporter State: MD
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2024

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: 11/30/2018
• Device Model Number: 72404239
• Device Catalogue Number: 72404239
• Device Lot Number: 0157624003
• 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: 09/24/2024
• Supplement Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 10/11/2024
• Supplement Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2016
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Unknown