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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 Entrapment of Device (1212); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/22/2021
Event Type  malfunction  
Event Description
It was reported that foreign material was observed on the device and the device entrapment occurred.The target lesion was located in the moderately tortuous and severely calcified right coronary artery.A 1.25mm and a rotawire guidewire were selected for use.During the procedure, the 1.25mm burr was used but the proximal surface of the burr was stuck in the drive shaft sheath.The burr was completely removed from the patient's body together with the rotawire.A 1.5mm rotalink plus burr was selected to continue the procedure but a foreign object was stuck between the burr and the rotawire and the advancer did not move.The 1.5mm rotalink plus burr was also completely removed together with the rotawire and the procedure was completed with nc balloon catheter.No complications were reported and the patient was good post procedure.
 
Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.Microscopic and visual inspection of the device presented no damages.Functional test was performed and the rotawire was able to be passed through the related rotablator device with no resistance or issues.Dimensional inspection was performed and the measured dimensions were within specification.No issues were identified during the product analysis.
 
Event Description
It was reported that foreign material was observed on the device and the device entrapment occurred.The target lesion was located in the moderately tortuous and severely calcified right coronary artery.A 1.25mm and a rotawire guidewire were selected for use.During the procedure, the 1.25mm burr was used but the proximal surface of the burr was stuck in the drive shaft sheath.The burr was completely removed from the patient's body together with the rotawire.A 1.5mm rotalink plus burr was selected to continue the procedure but a foreign object was stuck between the burr and the rotawire and the advancer did not move.The 1.5mm rotalink plus burr was also completely removed together with the rotawire and the procedure was completed with nc balloon catheter.No complications were reported and the patient was good post procedure.
 
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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 Key11467033
MDR Text Key239420851
Report Number2134265-2021-03123
Device Sequence Number1
Product Code MCX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 06/21/2021
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
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/11/2021
Initial Date Manufacturer Received 02/22/2021
Initial Date FDA Received03/11/2021
Supplement Dates Manufacturer Received06/18/2021
Supplement Dates FDA Received06/21/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
BURR: 1.5MM ROTALINK PLUS; BURR: 1.5MM ROTALINK PLUS
Patient Age80 YR
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