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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAWIRE AND WIRECLIP TORQUER; CATHETER, CORONARY, ATHERECTOMY

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BOSTON SCIENTIFIC CORPORATION ROTAWIRE AND WIRECLIP TORQUER; CATHETER, CORONARY, ATHERECTOMY Back to Search Results
Catalog Number 22824-002
Device Problem Break (1069)
Patient Problem Insufficient Information (4580)
Event Date 06/25/2021
Event Type  malfunction  
Event Description
Per report, atherectomy performed to a very calcified left anterior descending artery (lad), followed by a des stent placement.The tip of the rotawire broke off in the small distal branch of the lad and decision made by cardiologist to not attempt retrieval.Thus, considered an un-retrieved device fragment.
 
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Brand Name
ROTAWIRE AND WIRECLIP TORQUER
Type of Device
CATHETER, CORONARY, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key12466613
MDR Text Key271284702
Report Number12466613
Device Sequence Number1
Product Code MCX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 09/01/2021,07/13/2021
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 No Information
Device Catalogue Number22824-002
Device Lot Number26613407
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/01/2021
Date Report to Manufacturer09/14/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/14/2021
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age27740 DA
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