MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINNETONKA AMS INFLATABLE PENILE PROSTHESIS; DEVICE, IMPOTENCE, MECHANICAL/HYDRAULIC

Model Number 72403337

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Information (3190)

Event Date 06/28/2018

Event Type  Injury  

Manufacturer Narrative

Analysis results indicated there was a device failure related to the reported event.

Event Description

It was reported the patient has a planned inflatable penile prosthesis (ipp)revision procedure due to pump fluid loss.The physician reported ¿the device worked very well until 2 weeks ago and now the pump seems empty.We have ordered an mri of the pelvis to confirm this but the prosthesis should be replaced when possible.¿ no patient complications were reported in relation to this event.It was subsequently reported the patient previously had a replacement surgery of the ipp due to fluid loss.No other patient information was reported.This complaint was initially submitted to fda via asr report q2 2018 and additional information was received by boston scientific.Due to the removal of exemption (b)(4), this information is provided via supplemental report.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS
• Type of Device: DEVICE, IMPOTENCE, MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - MINNETONKA; 10700 bren road w; minnetonka MN 55343
• Manufacturer (Section G): BOSTON SCIENTIFIC - MINNETONKA; 10700 bren road w; minnetonka MN 55343
• Manufacturer Contact: sharon zurn ; 10700 bren road w; minnetonka, MN 55343 ; 9529306000
• MDR Report Key: 8651408
• MDR Text Key: 146418876
• Report Number: 2183959-2019-00024
• Device Sequence Number: 1
• Product Code: FHW
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: N970012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/14/2018

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/15/2016
• Device Model Number: 72403337
• Device Catalogue Number: 72403337
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2019
• Initial Date FDA Received: 05/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR