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

Model Number 72404232

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/07/2019

Event Type  malfunction  

Manufacturer Narrative

Model number/catalog number: 72404155, serial number null batch/lot number: (b)(4), model/catalog description: reservoir 65 ml pc/iz.

Event Description

It was reported that the patient indicated experiencing inflation issues with an 8 year old inflatable penile prosthesis (ipp).The patient noticed that the cylinders were "severely deflated" and when the patient tried to activate the device, the pump would deflate and not allow any further pumping.It was also expressed that clicking the release button, and squeezing the sides of the pump worked in refilling it, however that was "all it appeared to be doing".The patient also mentioned attempting both pumping methods several times with no results.Patient liaison was contacted and it was recommended to schedule an appointment for assessment.Product performance analyst (ppa) was unable to request further information, as customer contact for the account is unknown.No more information available at the moment.Should additional information become available, it will be provided.Additional information was received in which it was reported that the patient had an ultrasound completed.In the ultrasound it was determined that the reservoir was over half empty of fluid.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: 8843137
• MDR Text Key: 152784387
• Report Number: 2183959-2019-65393
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953003450
• UDI-Public: 00878953003450
• Combination Product (y/n): N
• PMA/PMN Number: N970012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/20/2013
• Device Model Number: 72404232
• Device Catalogue Number: 72404232
• Device Lot Number: 692113001
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/12/2019
• Initial Date FDA Received: 07/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2011
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 50 YR