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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERIPHERAL ROTAWIRE AND WIRECLIP TORQUER; CATHETER, PERIPHERAL, ATHERECTOMY
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BOSTON SCIENTIFIC CORPORATION PERIPHERAL ROTAWIRE AND WIRECLIP TORQUER; CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Model Number 29711
Device Problems Detachment of Device or Device Component (2907); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/15/2024
Event Type  Injury  
Event Description
It was reported that the wire detached, and additional surgery was required.The 90% stenosed target lesion was located in the severely calcified artery.A rotawire was selected for atherectomy.During procedure, following rotablation, a sterling balloon would not advance over the wire and the wire appeared kinked.The wire then broke into two pieces, mid wire.Furthermore, the patient underwent endarterectomy and the distal end of the rotawire was successfully removed.The procedure was completed.No patient complications were reported.
 
Manufacturer Narrative
D4: lot number: corrected from unknown to (b)(4).
 
Event Description
It was reported that the wire detached, and additional surgery was required.The 90% stenosed target lesion was located in the severely calcified artery.A rotawire was selected for atherectomy.During procedure, following rotablation, a sterling balloon would not advance over the wire and the wire appeared kinked.The wire then broke into two pieces, mid wire.Furthermore, the patient underwent endarterectomy and the distal end of the rotawire was successfully removed.The procedure was completed.No patient complications were reported.
 
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Brand Name
PERIPHERAL ROTAWIRE AND WIRECLIP TORQUER
Type of Device
CATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC DE COSTA RICA S.R.L.
302 parkway, global park
la aurora - heredia
CS  
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key18848565
MDR Text Key337028420
Report Number2124215-2024-11689
Device Sequence Number1
Product Code MCW
UDI-Device Identifier08714729838890
UDI-Public08714729838890
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121774
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/08/2024
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received03/06/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number29711
Device Catalogue Number29711
Device Lot Number0032895339
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/18/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/20/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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