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

Model Number	72404011
Medical Device Problem Codes	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	07/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had the inflatable penile prosthesis removed due to a macro puncture in the cylinder.A new inflatable penile prosthesis was implanted.No patient complications were reported.
Event or Problem Description
It was reported that the patient had the inflatable penile prosthesis removed due to a macro puncture in the cylinder.A new inflatable penile prosthesis was implanted.No patient complications were reported.
Additional Manufacturer Narrative
Upon receipt of this inflatable penile prosthesis at our quality assurance laboratory, the returned components underwent a thorough analysis.Both cylinders were visually inspected, and leak tested.The first cylinder had a hole from a sharp instrument in the proximal end of the cylinder.This cylinder had broken fabric threads from wear in the proximal end of the cylinder.The second cylinder had no visual damages or abnormalities found.The pump was visually inspected, and leak tested.Under microscope observation, contamination of bodily fluid was found within the pump.The pump passed the leak test.The pump was not functionally tested due to the contamination.The reservoir was visually inspected, and leak tested.The reservoir passed visual inspection and there were no visual damages or abnormalities found.The reservoir passed leakage test.Based on the information available and analysis results, the reported puncture was unable to be confirmed and the cause was not able to be established.

• 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: 17544667
• Report Number: 2124215-2023-43342
• Device Sequence Number: 6430417
• Product Code: FHW
• UDI-Device Identifier: 00878953002682
• UDI-Public: 00878953002682
• 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: 2019
• Device Explanted Year: 2023
• 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): 09/28/2023

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 Expiration Date: 06/22/2026
• Device Model Number: 72404011
• Device Catalogue Number: 72404011
• Device Lot Number: 1000586281
• 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: 07/24/2023
• Supplement Date Received by Manufacturer: 09/20/2023
• Initial Report FDA Received Date: 08/14/2023
• Supplement Report FDA Received Date: 09/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2021
• 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 1100257093; PUMP UPN 72404310 LOT 1100257093; RESERVOIR UPN 72404161 LOT 1100294138; RESERVOIR UPN 72404161 LOT 1100294138
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male