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

Model Number	72404282
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2023
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 after the inflatable penile prosthesis (ipp) device was implanted, the patient was not able to fully inflate the device in order to achieve an erection.The physician tried to adjust the device outside the patient but was unable to inflate the device.After surgical exploration and still being unable to inflate the device, the physician explanted the ipp device nine days after it was originally implanted.
Additional Manufacturer Narrative
Upon receipt at of the inflatable penile prosthesis (ipp) cylinders and reservoir at our quality assurance laboratory, the returned components underwent a thorough analysis.Visual examination identified a hole in the proximal end of cylinder 1 due to a sharp instrument.There was a fluid leak from the hole.Cylinder 2 passed functional testing and was found to not have any leaks.The pump passed visual inspection, functional testing, and was found to not have any leaks.The reservoir passed visual inspection, functional testing, and was found to not have any leaks.Based on the information available and analysis results, the hole and fluid leak from cylinder 1 likely led to the reported device inflation issues.
Event or Problem Description
It was reported that after the inflatable penile prosthesis (ipp) device was implanted, the patient was not able to fully inflate the device in order to achieve an erection.The physician tried to adjust the device outside the patient but was unable to inflate the device.After surgical exploration and still being unable to inflate the device, the physician explanted the ipp device nine days after it was originally implanted.

• 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: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 17043998
• Report Number: 2124215-2023-27891
• Device Sequence Number: 3454964
• Product Code: FHW
• UDI-Device Identifier: 00878953003856
• UDI-Public: 00878953003856
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 08/31/2023

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 Model Number: 72404282
• Device Catalogue Number: 72404282
• Device Lot Number: 1100143430
• 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: 05/15/2023
• Supplement Date Received by Manufacturer: 08/11/2023
• Initial Report FDA Received Date: 06/01/2023
• Supplement Report FDA Received Date: 08/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2022
• 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: PRODUCT: RESERVOIR, UPN: 720182-01, LOT:1100127344; PRODUCT: RESERVOIR, UPN: 720182-01, LOT:1100127344
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 75 KG