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

Model Number	72404293
Medical Device Problem Codes	Mechanical Problem (1384); Material Puncture/Hole (1504); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Based on the information available, the cause that contributed to the reported event cannot be established; a conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
It was reported that the patient presented with an inflatable penile prosthesis (ipp) that did not work as intended.Surgical intervention was performed to revise the device, and the physician found the left cylinder had a tear.The pump and cylinder were replaced.There were no patient complications reported.
Additional Manufacturer Narrative
Upon receipt of the inflatable penile prosthesis (ipp) at our quality assurance laboratory, the returned components underwent a thorough analysis.Examination of the cylinders found that one cylinder had wear at a fold in the middle of the cylinder body.There was also a hole in the middle of the cylinder resulting in a fluid leak, which was consistent with sharp instrument damage.The other cylinder also presented a hole with broken fabric threads and resulted in a fluid leak.This hole was consistent with sharp instrument damage, as well.This cylinder did show wear at a fold in the middle of the cylinder, and a hold was identified in the outer tube from wear.Inspection of the pump found contamination of the pump, and the kink resistant tubing (krt) was worn to the filament.The contamination of the pump made it unable to be functionally tested.Based on the information available, the reported allegations were able to be confirmed.
Event or Problem Description
It was reported that the patient presented with an inflatable penile prosthesis (ipp) that did not work as intended.Surgical intervention was performed to revise the device, and the physician found the left cylinder had a tear.The pump and cylinder were replaced.There were no patient complications reported.

• 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
• 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 ; 5086521217
• MDR Report Key: 18861157
• Report Number: 2124215-2024-13808
• Device Sequence Number: 11589922
• Product Code: FHW
• UDI-Device Identifier: 00878953003955
• UDI-Public: 00878953003955
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2024

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: 01/29/2024
• Device Model Number: 72404293
• Device Catalogue Number: 72404293
• Device Lot Number: 1000223713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/20/2024
• Supplement Date Received by Manufacturer: 05/22/2024
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2019
• 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: PUMP UPN 72404310 LOT 1000245562; PUMP UPN 72404310 LOT 1000245562; RESERVOIR: UPN 720182-01 LOT 1000262503; RESERVOIR: UPN 720182-01 LOT 1000262503
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male