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

Model Number 72404239

Device Problems Inadequacy of Device Shape and/or Size (1583); Device Misassembled During Manufacturing /Shipping (2912)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 09/03/2020

Event Type  Injury  

Event Description

It was reported that the patient underwent a surgical procedure to downsize the cylinders of their inflatable penile prosthesis (ipp) due to an "s" shaped deformity caused by buckling of the oversized cylinders.Smaller cylinders were implanted while the pump from the original device was left in service.No patient outcome was reported.Additional information was received indicating the physician suspected the original cylinder labelling was correct but the cylinders were not of the correct size.The patient was reported to have a positive outcome following the procedure.

Manufacturer Narrative

Correction to adverse event or product problem and correction/additional information to describe event or problem.Device codes updated.Upon receipt of additional information it was determined this event does not meet reporting criteria as there was no allegation of device malfunction/deficiency and the observed patient condition arose as a result of user error.

Event Description

It was reported that the patient underwent a surgical procedure to downsize the cylinders of their inflatable penile prosthesis (ipp) due to an "s" shaped deformity caused by buckling of the oversized cylinders.Smaller cylinders were implanted while the pump from the original device was left in service.No patient outcome was reported.Additional information was received indicating the device was determined to be the incorrect size for the patient.The physician believes the patient did not begin cycling the device in time causing a pseudocapsule to form resulting in 1-2 cm of shrinkage in the patient's corporal bodies and the observed "s" deformity in the cylinder.The patient had a positive outcome following the procedure.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
• Type of Device: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 11057946
• MDR Text Key: 223209811
• Report Number: 2183959-2020-06040
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953003528
• UDI-Public: 00878953003528
• Combination Product (y/n): N
• PMA/PMN Number: N970012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/27/2021
• Device Model Number: 72404239
• Device Catalogue Number: 72404239
• Device Lot Number: 1000296914
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR