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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) ROTAWIRE ELITE¿ AND WIRECLIP¿ TORQUER CATHETER, CORONARY, ATHERECTOMY Back to Search Results
Model Number H802223301
Device Problem Fracture (1260)
Patient Problems Death (1802); Perforation of Vessels (2135)
Event Date 09/30/2015
Event Type  Death  
Manufacturer Narrative
(b)(4). Device evaluated by mfr: it is indicated that the device will not be returned for evaluation. A review of the batch history, historical trending and similar complaint trending review for the product family will be conducted. 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#2134265-2015-07216. It was reported that wire tip fracture, vessel perforation and patient death occurred. The chronic total occlusion target lesion was located in the heavily calcified (360 degrees worth) ostial/proximal right coronary artery (rca). A rotawire elite guide wire crossed via an antegrade approach. During advancement of a 1. 50mm rotalink plus burr at , the wire fractured and the burr perforated the vessel. The burr speed was 190-200k rpm at the time of the event. The burr and part of the wire was removed; however, 20-30cm of the distal wire was left inside the patient. A non-bsc covered stent was deployed to seal the vessel perforation. 4 days later, the patient died.
 
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Brand NameROTAWIRE ELITE¿ AND WIRECLIP¿ TORQUER
Type of DeviceCATHETER, CORONARY, 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
linda leimer
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key5184724
MDR Text Key29733177
Report Number2134265-2015-07215
Device Sequence Number1
Product Code MCX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P900056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Remedial Action Recall
Type of Report Initial
Report Date 10/01/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/09/2017
Device Model NumberH802223301
Device Catalogue Number22330
Device Lot Number18282032
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 Received10/01/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/18/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction Number91098167FA

Patient Treatment Data
Date Received: 10/28/2015 Patient Sequence Number: 1
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