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

Model Number	72404011
Medical Device Problem Codes	Mechanical Problem (1384); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient went to the hospital due to the inflatable penile prosthesis (ipp) not working appropriately.Two weeks later a surgical procedure was performed in which the existing device was removed and replaced.Upon explant, a hole was identified in the left cylinder; however, its cause was not detailed by the facility.There were no patient complications reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this ams 700 underwent a thorough analysis.The cylinders were visually inspected, and leak tested.The first cylinder had wear at a fold in the proximal side of the component.Additionally, a hole was identified on the distal portion of the cylinder; however, this was consistent with sharp instrument damage.The second cylinder presented wear at a fold in the proximal side.The second cylinder passed the leak test.Visual analysis of the reservoir identified wear at a fold in the shell; however, the reservoir passed the leakage test.The pump was visually inspected, not revealing any damage or abnormality.Upon functional testing, the pump did not pass the activation tests 2 and 3.Based on the information available and analysis results, the pump not passing the activation tests 2 and 3 could have caused or contributed to the reported clinical observation of the ams 700 not working properly.A conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that the patient went to the hospital due to the inflatable penile prosthesis (ipp) not working appropriately.Two weeks later a surgical procedure was performed in which the existing device was removed and replaced.Upon explant, a hole was identified in the left cylinder; however, its cause was not detailed by the facility.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: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 17083252
• Report Number: 2124215-2023-29118
• Device Sequence Number: 6244145
• 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: 2016
• 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): 08/16/2023

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: 05/08/2020
• Device Model Number: 72404011
• Device Catalogue Number: 72404011
• Device Lot Number: 935068001
• 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: 05/22/2023
• Supplement Date Received by Manufacturer: 07/28/2023
• Initial Report FDA Received Date: 06/07/2023
• Supplement Report FDA Received Date: 08/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2015
• 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: 72404310/132417004; PUMP: 72404310/132417004; RESERVOIR: 72404161/132294020; RESERVOIR: 72404161/132294020
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Male