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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
Device Problems Fracture (1260); Difficult to Remove (1528)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/08/2023
Event Type  malfunction  
Event Description
It was reported that the burr and wire were fractured and became stuck inside the patient.A 1.25mm rotapro and rotawire were selected for use.During procedure, it was noted that the burr and wire were fractured and became stuck inside the patient.No further information is available.
 
Event Description
It was reported that the burr and wire were fractured and became stuck inside the patient.A 1.25mm rotapro and rotawire were selected for use.During procedure, it was noted that the burr and wire were fractured and became stuck inside the patient.No further information is available.
 
Manufacturer Narrative
Device evaluated by manufacturer: returned product consisted of a portion of the rotawire ic.The proximal end and wire body were visually and microscopically examined.Inspection of the device found that 222cm of the rotawire had been returned and that the wire was fractured at the distal end.Product analysis confirmed the reported fracture, as the returned rotawire was fractured.The reported rotawire becoming stuck within the lesion was not able to be confirmed as clinical circumstances were not able to be replicated.
 
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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
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key18446943
MDR Text Key332146371
Report Number2124215-2023-75108
Device Sequence Number1
Product Code MCX
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/25/2024
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
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/18/2023
Initial Date FDA Received01/04/2024
Supplement Dates Manufacturer Received03/06/2024
Supplement Dates FDA Received03/25/2024
Was Device Evaluated by Manufacturer? Yes
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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