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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) PERIPHERAL ROTAWIRE¿ AND WIRECLIP® TORQUER CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Model Number M0011373321
Device Problems Fracture (1260); 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
Device evaluated by mfr: the device was returned for analysis. Visual inspection revealed that the body of the rotawire was broken at approximately 238. 2cm from the proximal end. The other section measures approximately 92. 1cm from the distal tip. No foreign matters were found. Dimensional inspection of the overall length could not be performed due to device condition. The outer diameter (od) of distal tip, the middle and of the proximal section of the device were within specification. The investigation conclusion is user / use error as there was an act or omission of an act that resulted in a different medical device response than intended by the manufacturer or expected by the user. Dfu states: "do not allow the individual burr run time to exceed 30 seconds as this may lead to wire fracture/tip separation that may result in perforation, dissection, embolism, myocardial infarction and in rare cases, death. The rotawire guidewire has an expected functional life of 5 minutes (total of individual burr run times). Do not allow the burr to remain in one location while rotating at high speeds, as this may lead to wear of the guidewire. Gently advance or retract the burr while it is in high-speed rotary motion. In instances when long ablation runs are required - particularly in calcified, angulated lesions - reposition the guidewire to expose a previously unused segment or exchange the guidewire to prevent damage. " (b)(4).
 
Event Description
Same case as mdr id: 2134265-2017-13374 and 2134265-2018-00424. 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.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Same case as mdr id: 2134265-2017-13374 and 2134265-2018-00424. 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 (HEREDIA)
302 parkway
la aurora
heredia
CS
Manufacturer (Section G)
BOSTON SCIENTIFIC - COSTA RICA (HEREDIA)
302 parkway
la aurora
heredia
CS
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key7205504
MDR Text Key263080854
Report Number2134265-2017-13373
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,Followup
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 Expiration Date10/11/2019
Device Model NumberM0011373321
Device Lot Number21245210
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/04/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/31/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/11/2017
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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