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

Model Number 72404262

Device Problems Inadequacy of Device Shape and/or Size (1583); Defective Device (2588)

Patient Problem Scarring (2061)

Event Date 06/19/2020

Event Type  Injury  

Event Description

It was reported that the patient was not happy with the fit of an inflatable penile prosthesis (ipp).A surgical procedure was performed in which it was noticed that the right side was 2 cm shorter than the left but the measurements were the same.This unevenness was suspected to be due to the device not being placed correctly due to scar tissue.During the procedure the existing 14 cm preconnected ipp was removed and a new 15 cm one was implanted; the existing reservoir remained implanted on the right side.There were no device malfunctions associated with the explanted device.The unevenness was fixed with the implant of the new ipp.The device did not cause or contribute to the scar tissue or other patient complications.

• 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
• Manufacturer (Section G): AMERICAN MEDICAL SYSTEMS LLC; 10700 bren road west; minnetonka MN 55343
• Manufacturer Contact: alyson harris ; 10700 bren road w; minnetonka, MN 55343 ; 4083953452
• MDR Report Key: 10239183
• MDR Text Key: 197758985
• Report Number: 2183959-2020-02822
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953003702
• UDI-Public: 00878953003702
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N970012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/25/2018
• Device Model Number: 72404262
• Device Catalogue Number: 72404262
• Device Lot Number: 0153956005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR