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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) PERIPHERAL ROTAWIRE¿ AND WIRECLIP® TORQUER CATHETER, PERIPHERAL, ATHERECTOMY

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BOSTON SCIENTIFIC - COSTA RICA (COYOL) PERIPHERAL ROTAWIRE¿ AND WIRECLIP® TORQUER CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Model Number M0011373321
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/28/2017
Event Type  malfunction  
Manufacturer Narrative
The device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed. (b)(4).
 
Event Description
Same case as mdr id: 2134265-2017-13373 and 2134265-2017-13374. It was reported that foreign matter was observed on the rotawire and a rotawire fracture occurred. The target lesion was located in the anterior tibial artery of the right lower leg. A peripheral rotawire and a peripheral rotalink plus were selected for use. There were two rotawires that were pulled out from its hoop and white debris was observed at the proximal end. Subsequently, the second rotawire was used during platforming. When the physician loaded the rotaburr onto the rotawire, it was noted that the wire snapped in half. The rotawire was exchanged with another of the same device and the rotaburr was loaded onto it. However, the burr was unable to load onto the wire. The procedure was completed with another of the same rotaburr. No patient complications were reported and the patient's status was fine.
 
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Brand NamePERIPHERAL ROTAWIRE¿ AND WIRECLIP® TORQUER
Type of DeviceCATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC - COSTA RICA (COYOL)
2546 first street
propark free zone
alajuela
CS
Manufacturer (Section G)
BOSTON SCIENTIFIC - COSTA RICA (COYOL)
2546 first street
propark free zone
alajuela
CS
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key7205522
MDR Text Key97899416
Report Number2134265-2018-00424
Device Sequence Number1
Product Code MCW
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 company representative,health
Reporter Occupation
Type of Report Initial
Report Date 12/28/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM0011373321
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/28/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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