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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE COMET; TRANSDUCER, PRESSURE, CATHETER TIP
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BOSTON SCIENTIFIC - MAPLE GROVE COMET; TRANSDUCER, PRESSURE, CATHETER TIP Back to Search Results
Model Number H7493932430
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/21/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a guidewire break occurred.The 80% stenosed target lesion was located in the moderately tortuous and moderately calcified right coronary artery.A comet guidewire was in use when it was noted that the torque was weak.It was then noted that there was a break in the guidewire.The procedure was completed with another of the same device.There were no patient complications reported and the patient status was good.
 
Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a ffr comet wire separated in two pieces.The guidewire shaft was examined for any damage or irregularities.It was noticed that the device was separated when returned.The proximal end of the shaft measured 169.8cm.The distal end measured 15cm which is the total length of 185cm.The wire also showed a kink at 41cm from the proximal end of the shaft.The tip showed a bend.No other damage or irregularities were noticed.The sensor port was clear of any material.Functional testing of the device could not be completed due to the separation of the shaft.Because there was no evidence of any product quality deficiencies, it was considered likely that the tip damage was attributable to procedural factors.Materials testing analysis characterization (mtac) testing was performed on the returned device.Coating material was present in slots in rows 1 thru 7 adjacent to the distal and proximal fracture ends.No micro-cracks were observed at apex of slots in rows 1 thru 7 adjacent to the distal and proximal fracture ends.The distal laser cut slot surfaces appeared rough and irregular.The proximal laser cut slot surfaces show some smeared material.Scanning electron microscopy (sem) images of distal and proximal fractured beams appear to show some fatigue striations toward the center of the fracture.One beam fracture for each appears to show ductile region in the center.This suggests the possibility of a fatigue failure with ductile overload.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion was unable to be determined.(b)(4).
 
Event Description
It was reported that a guidewire break occurred.The 80% stenosed target lesion was located in the moderately tortuous and moderately calcified right coronary artery.A comet guidewire was in use when it was noted that the torque was weak.It was then noted that there was a break in the guidewire.The procedure was completed with another of the same device.There were no patient complications reported and the patient status was good.
 
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Brand Name
COMET
Type of Device
TRANSDUCER, PRESSURE, CATHETER TIP
Manufacturer (Section D)
BOSTON SCIENTIFIC - MAPLE GROVE
one scimed place
maple grove MN 55311
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key7115147
MDR Text Key95066204
Report Number2134265-2017-12304
Device Sequence Number1
Product Code DXO
Combination Product (y/n)N
Reporter Country CodeKR
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/23/2017
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
Device Expiration Date08/15/2019
Device Model NumberH7493932430
Device Lot Number21013924
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/12/2017
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/23/2017
Initial Date FDA Received12/13/2017
Supplement Dates Manufacturer Received01/12/2018
Supplement Dates FDA Received02/07/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/22/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age66 YR
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