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 ACUITY WHISPER VIEW; WIRE, GUIDE, CATHETER
  • 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 ACUITY WHISPER VIEW; WIRE, GUIDE, CATHETER Back to Search Results
Model Number 4648
Device Problems Difficult to Insert (1316); Material Integrity Problem (2978)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/03/2019
Event Type  malfunction  
Event Description
It was reported that multiple guidewires had been used during a difficult implant procedure.When the physician used the final wire, it was observed that approximately 3 centimeters of a different guidewire had broken off and was abandoned within the sinus coronary branch.The patient was stable with no additional consequences.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ACUITY WHISPER VIEW
Type of Device
WIRE, GUIDE, CATHETER
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
Manufacturer (Section G)
CARDIAC PACEMAKERS, INC.
4100 hamline ave n
,
st paul MN 55112
Manufacturer Contact
timothy degroot
4100 hamline avenue north
,
saint paul, MN 55112
6515826168
MDR Report Key8818687
MDR Text Key151952143
Report Number2124215-2019-14459
Device Sequence Number1
Product Code DQX
UDI-Device Identifier00802526512988
UDI-Public00802526512988
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K110479
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 07/23/2019
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 Health Professional
Device Expiration Date01/24/2021
Device Model Number4648
Device Catalogue Number4648
Device Lot Number23247511
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/03/2019
Initial Date FDA Received07/23/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/24/2019
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
-
-