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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 Problem Contamination (1120)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/15/2023
Event Type  malfunction  
Event Description
It was reported that contamination occurred.A peripheral rotawire guidewire was selected for atherectomy procedure.During preparation, it was noted that there was a white smudge on the distal end of the rotawire.The device was not used, and the procedure was completed with another of the same device.There were no patient complications reported.
 
Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.During microscopic inspection it was found that the distal side of the guidewire has a white smudge.
 
Event Description
It was reported that contamination occurred.A peripheral rotawire guidewire was selected for atherectomy procedure.During preparation, it was noted that there was a white smudge on the distal end of the rotawire.The device was not used, and the procedure was completed with another of the same device.There were no patient complications 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 Key17270738
MDR Text Key318567671
Report Number2124215-2023-34583
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 09/26/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/06/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number29711
Device Catalogue Number29711
Device Lot Number0031266070
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/06/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/20/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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