Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS INFLATABLE PENILE PROSTHESIS; DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION AMS INFLATABLE PENILE PROSTHESIS; DEVICE IMPOTENCE MECHANICAL/HYDRAULIC Back to Search Results
Model Number 72404310
Device Problems Collapse (1099); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/09/2020
Event Type  Injury  
Event Description
It was reported that due to the device no longer working because the bulb on the pump stayed flat when pressing, the patient had his inflatable penile prosthesis (ipp) pump removed and replaced.It was added that this issue was identified two weeks before this surgery.The patient was noted as stable following this surgery.
 
Manufacturer Narrative
Evaluation: the product record review indicated that the reported events do not represent an unanticipated event.Review of the manufacturing documentation confirmed all required in-process and final inspections and testing were completed.Based on this investigation, the investigation conclusion code of 'cause traced to component failure' was chosen because the reported events could be traced to a component failure.Based on the results of this investigation, no escalation is required.This conclusion is supported by the following objective evidence: product analysis summary: product analysis confirmed the reported event related to pump collapse.The ams 700 momentary squeeze (ms) pump was visually inspected.The kink resistant tubing (krt) was worn to the filament; however, no leaks were present.The pump was functionally tested and failed activation test.Product analysis confirmed the reported event.Dhr review / similar complaint review: review of manufacturing documentation was performed to ensure that all required in-process and final inspections and testing were completed.Review of the manufacturing records for batch: 1000072179 and it respective container 21860019, found no evidence that the device failed to meet applicable product specifications prior to shipment from boston scientific.Additionally, potential emerging trends are captured as part of the post market signal evaluation and escalation process.Risk review: the ams 700 hazard analysis indicates that the as reported events of this complaint do not represent a new hazardous situation.Additionally, boston scientific does not have responsibility to provide training to medical professional as documented in the dfu/ifu, and the ams 700 is not a new product because it is not within the first six months of its release in any geography, and it is not a new design platform.No further review is required.
 
Event Description
It was reported that due to the device no longer working because the bulb on the pump stayed flat when pressing, the patient had his inflatable penile prosthesis (ipp) pump removed and replaced.It was added that this issue was identified two weeks before this surgery.The patient was noted as stable following this surgery.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
AMS INFLATABLE PENILE PROSTHESIS
Type of Device
DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
10700 bren road w
minnetonka MN 55343
MDR Report Key10215612
MDR Text Key197086236
Report Number2183959-2020-02749
Device Sequence Number1
Product Code FHW
UDI-Device Identifier00878953003986
UDI-Public00878953003986
Combination Product (y/n)N
PMA/PMN Number
N970012
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 08/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date03/14/2023
Device Model Number72404310
Device Catalogue Number72404310
Device Lot Number1000072179
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/13/2020
Date Manufacturer Received07/16/2020
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age73 YR
-
-