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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACUITY WHISPER VIEW; WIRE, GUIDE, CATHETER
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BOSTON SCIENTIFIC CORPORATION ACUITY WHISPER VIEW; WIRE, GUIDE, CATHETER Back to Search Results
Model Number 4643
Device Problems Difficult to Insert (1316); Difficult to Remove (1528); Material Twisted/Bent (2981)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/10/2019
Event Type  malfunction  
Event Description
It was reported that during the implant procedure, the physician experienced difficulty removing the guidewire through the lead.The original lead was able to be implanted and no patient consequences were reported.
 
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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 Key8524030
MDR Text Key142253124
Report Number2124215-2019-06470
Device Sequence Number1
Product Code DQX
UDI-Device Identifier00802526512889
UDI-Public00802526512889
Combination Product (y/n)N
Reporter Country CodeGM
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 04/17/2019
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 Date08/23/2020
Device Model Number4643
Device Catalogue Number4643
Device Lot Number22562988
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/04/2019
Initial Date FDA Received04/17/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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