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

Model Number 72404252-10

Device Problems Collapse (1099); Inflation Problem (1310); Defective Device (2588)

Patient Problem Capsular Contracture (1761)

Event Date 11/27/2019

Event Type  Injury  

Manufacturer Narrative

Model number/catalog number: 72404155, serial number: null ,batch/lot number: 1000325389, model/catalog description reservoir: 65 ml pc/iz.

Event Description

It was reported that the patient experienced a hard time pumping and inflatable penile prosthesis (ipp).A surgical procedure was performed in which the existing pump was removed and replaced with a new one.The patient did not experience any further complications.It was further reported that the patient was having difficulty inflating the device due to a capsule that formed around the pump.The device also presented a "sticky pump" as it would pump once or twice and then remained flat which caused the physician and patient to be unhappy with the outcome, leading to the procedure.The onset of the symptoms was shortly after ipp implantation.The patient was said to be good after the procedure.No more information available at the moment.Should additional information become available, it will be provided.

• 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): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• Manufacturer Contact: alyson harris ; 10700 bren road w; minnetonka, MN 55343 ; 4083953452
• MDR Report Key: 9484276
• MDR Text Key: 171780114
• Report Number: 2183959-2019-68200
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953009810
• UDI-Public: 00878953009810
• 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: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/18/2021
• Device Model Number: 72404252-10
• Device Catalogue Number: 72404252-10
• Device Lot Number: 1000318893
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR