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

Model Number 72404232-10

Device Problems Collapse (1099); Failure to Cycle (1142); Inflation Problem (1310)

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

Event Date 05/15/2020

Event Type  Injury  

Event Description

It was reported that the patient underwent an inflatable penile prosthesis (ipp) procedure due to the patient experienced inflation issues. Patient requested that pump be replaced. Attempts to operate the pump prior to incision were done but it did not improve. Fluid would move into the cylinders from the pump, but fluid would not return to the pump from the reservoir. The pump valve stayed flat. The pump was replaced. New pump worked great intra op and immediately post-op. No further patient complications were reported.

• 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 ; 4089353452
• MDR Report Key: 10118776
• MDR Text Key: 193980772
• Report Number: 2183959-2020-02423
• Device Sequence Number: 1
• Product Code: FHW
• 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

• Type of Report: Initial,Followup
• Report Date: 07/02/2020

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 06/04/2020
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: LAY USER/PATIENT
• Device EXPIRATION Date: 01/15/2021
• Device MODEL Number: 72404232-10
• Device Catalogue Number: 72404232-10
• Device LOT Number: 1000215592
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 06/01/2020
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/26/2020
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 01/16/2019
• Is The Device Single Use?: Yes

Is this a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Initial

Patient TREATMENT DATA

Date Received: 06/04/2020 Patient Sequence Number: 1