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

Model Number 72404252-10

Device Problems Mechanical Problem (1384); Defective Device (2588); Free or Unrestricted Flow (2945)

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

Event Date 05/12/2020

Event Type  malfunction  

Manufacturer Narrative

Model number/catalog number 720185-01 serial number null batch/lot number 1000366391 model/catalog description reservoir flat iz 100 ml.

Event Description

It was reported that the patient stated having difficulty pumping an inflatable penile prosthesis (ipp) due to the bulb being "rock hard" and when able to squeeze the bulb the fluid did not stay in the cylinders.Patient indicated that the physician couldn't get the device to work properly either.Patient liaison provided reboot instructions including burping and anti-stiction.The patient would try the techniques and follow up if needed.

• 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: 10069438
• MDR Text Key: 193282381
• Report Number: 2183959-2020-02270
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953009810
• UDI-Public: 00878953009810
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/20/2021
• Device Model Number: 72404252-10
• Device Catalogue Number: 72404252-10
• Device Lot Number: 1000293798
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 67 YR