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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
Model Number 3520
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/17/2021
Event Type  malfunction  
Event Description
It was reported that a foreign material present on the rotawire.A 330cm rotawire was selected for use.During procedure, after ablation by a 1.5mm rotaburr, the physician tried to use a bigger size of 2.0mm, but it was unable to advance just near the entrance of the guiding catheter.The burr was replaced with a new device, but it was also unable to advance at the same area, so usage was discontinued.After the procedure, when it was checked outside the body, it advanced without resistance.As per checking on the rotawire, it was noted that there were fiber-like material found on the wire at the section between marks applied by the customer.It was thought that there may have been an issue at that section and resulted in something such as gauze got tangled.It was also reported that there was no known issue noted on the burr.The procedure was completed with the original device.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.The guidewire was carefully inspected and some fibers were found at 117.2cm and 118cm from the distal tip.
 
Event Description
It was reported that a foreign material present on the rotawire.A 330cm rotawire was selected for use.During procedure, after ablation by a 1.5mm rotaburr, the physician tried to use a bigger size of 2.0mm, but it was unable to advance just near the entrance of the guiding catheter.The burr was replaced with a new device, but it was also unable to advance at the same area, so usage was discontinued.After the procedure, when it was checked outside the body, it advanced without resistance.As per checking on the rotawire, it was noted that there were fiber-like material found on the wire at the section between marks applied by the customer.It was thought that there may have been an issue at that section and resulted in something such as gauze got tangled.It was also reported that there was no known issue noted on the burr.The procedure was completed with the original device.No patient complications were reported.It was further reported that the issue occurred when the rotaburr was at near the connection part of the guiding catheter and y-connector.There was no issue with the concomitant non boston scientific guiding catheter.The rotaburrs became unable to advance on the rotawire and not likely in the lumen of the guiding catheter.The physician's comment was it seems that the issue was the burr failed to track over the wire due to wire and that the issue was due to the burr.However, there was no issue noted with the burr when checked outside patient's body.
 
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Brand Name
ROTAWIRE AND WIRECLIP TORQUER
Type of Device
CATHETER, CORONARY, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key11466384
MDR Text Key239422445
Report Number2134265-2021-02786
Device Sequence Number1
Product Code MCX
UDI-Device Identifier08714729195566
UDI-Public08714729195566
Combination Product (y/n)N
PMA/PMN Number
P900056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 04/11/2021
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 Health Professional
Device Expiration Date01/16/2022
Device Model Number3520
Device Catalogue Number3520
Device Lot Number0025060816
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/10/2021
Initial Date Manufacturer Received 02/19/2021
Initial Date FDA Received03/11/2021
Supplement Dates Manufacturer Received03/23/2021
Supplement Dates FDA Received04/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
GUIDE CATHETER: LAUNCHER/MDT
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