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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SAMURAI; CATHETER, GUIDEWIRE
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BOSTON SCIENTIFIC CORPORATION SAMURAI; CATHETER, GUIDEWIRE Back to Search Results
Model Number 2842
Device Problem Fracture (1260)
Patient Problem Chest Pain (1776)
Event Date 10/23/2020
Event Type  Injury  
Event Description
It was reported that guidewire fracture occurred and the patient experienced chest pain.The 95% stenosed target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 190cm, straight-tip samurai guidewire was advanced to cross the lesion.However, during the procedure, the guidewire fractured.It took a very long time to cross the lesion, once the wire crossed the lesion the patient started having chest pain so the physician opted to continue with using the same guidewire.The wire was removed intact and no patient injury was reported.
 
Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.Examination of the returned product showed a large curve within approximately 15 mm from the distal tip and pitch elongation of 3 wraps of the coil.
 
Event Description
It was reported that guidewire fracture occurred and the patient experienced chest pain.The 95% stenosed target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 190cm, straight-tip samurai guidewire was advanced to cross the lesion.However, during the procedure, the guidewire fractured.It took a very long time to cross the lesion, once the wire crossed the lesion the patient started having chest pain so the physician opted to continue with using the same guidewire.The wire was removed intact and no patient injury was reported.
 
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Brand Name
SAMURAI
Type of Device
CATHETER, GUIDEWIRE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key10816643
MDR Text Key215506845
Report Number2134265-2020-15503
Device Sequence Number1
Product Code DQX
UDI-Device Identifier08714729881216
UDI-Public08714729881216
Combination Product (y/n)N
PMA/PMN Number
K151840
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 01/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/13/2022
Device Model Number2842
Device Catalogue Number2842
Device Lot Number0023345301
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/30/2020
Date Manufacturer Received01/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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