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

Model Number	72404272
Medical Device Problem Codes	Degraded (1153); Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2023
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.Neither the reported patient symptoms or device performance allegation can be confirmed.Based on the information available, a conclusion code of no problem detected 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, the patient underwent a revision surgery in which the pump and cylinders were replaced.Upon explant, a cylinder bulge was noted; however, its cause was not detailed by the facility.It was noted that during the surgery a set of cylinders were accidentally dropped on the floor; therefore, a different ipp was used to complete the procedure.There were no patient complications.
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 middle of the cylinder.The component also presented holes from the corner of a fold in the middle of the cylinder body; however, the cylinder passed both the leakage test and the pressure test.Visual inspection of the second cylinder identified wear at a fold in the middle of the cylinder.The component passed leakage test.The pump was visually inspected, and leak tested.It was identified that the tubing was cut down to the pump block and not returned for analysis.The pump passed the leak test.Upon functional testing, the pump did not pass the activation tests 2 and 3.Based on the information available and analysis results, although the allegation of cylinder bulging could not be confirmed, the pump not passing the activation tests 2 and 3 could have caused or contributed to the reported clinical observation of the device not working appropriately.A conclusion code of cause traced to component failure was assigned to this investigation.Field h9 correction/removal reporting number refers to the pump component.Model number 72404310, lot number 1000215374 referenced as a concomitant product/therapy.
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, the patient underwent a revision surgery in which the pump and cylinders were replaced.Upon explant, a cylinder bulge was noted; however, its cause was not detailed by the facility.It was noted that during the surgery a set of cylinders were accidentally dropped on the floor; therefore, a different ipp was used to complete the procedure.There were no patient complications.

• 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
• MDR Report Key: 17639937
• Report Number: 2124215-2023-46048
• Device Sequence Number: 17562737
• Product Code: FHW
• UDI-Device Identifier: 00878953003795
• UDI-Public: 00878953003795
• 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
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2023

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: 09/17/2023
• Device Model Number: 72404272
• Device Catalogue Number: 72404272
• Device Lot Number: 1000160144
• 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: 08/11/2023
• Supplement Date Received by Manufacturer: 12/15/2023
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2018
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0427-2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PUMP: 72404310/1000215374; PUMP: 72404310/1000215374
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male