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

Model Number	72404235
Medical Device Problem Codes	Failure to Cycle (1142); Mechanical Problem (1384)
Health Effect - Clinical Code	Complaint, Ill-Defined (2331)
Date of Event	05/04/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a few months ago, the patient needed plastic treatment for lysis of skin flaps to try to relocate an inflatable prosthesis that did not work properly.During manipulation in the intraoperative period, the device did not present adequate cycling, corroborating a computed tomography study that documented the breakdown of the 3-volume inflatable device.The penile implant must be replaced and the urethral opening resulting from chronic use of a bladder catheter must be corrected simultaneously.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
• Common Device Name: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 10045807
• Report Number: 2183959-2020-02234
• Device Sequence Number: 3293265
• Product Code: FHW
• UDI-Device Identifier: 00878953003481
• UDI-Public: 00878953003481
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/11/2020

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: 02/17/2019
• Device Model Number: 72404235
• Device Catalogue Number: 72404235
• Device Lot Number: 0165257008
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/04/2020
• Initial Report FDA Received Date: 05/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MODEL # 720182-01LOT # 128300001
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 50 YR