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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION COMET; TRANSDUCER, PRESSURE, CATHETER TIP
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BOSTON SCIENTIFIC CORPORATION COMET; TRANSDUCER, PRESSURE, CATHETER TIP Back to Search Results
Model Number 8900
Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/29/2018
Event Type  Injury  
Event Description
It was reported that a guide wire break occurred.During this procedure a comet pressure guidewire was selected; however, after manipulation inside the lesion and some movement the pressure wire broke about 20cm from the distal end.An unspecified balloon was inflated which pressed the pressure wire against the vessel wall and they slowly removed everything from the lesion.The procedure was completed with another of the same device.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by manufacturer: the returned product consisted of a ffr comet wire separated.The distal portion of the device was not returned.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 164cm.The designed length of the comet wire is 185cm long, since only 164cm was returned 21cm was not returned from the customer site.The wire also showed 2 kinks.The kinks were located approximately 17cm and 36cm from the separated end of the proximal shaft.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.Scanning electron microscope (sem) and fractography on the break of the wire was performed and revealed an abnormal beam and a narrow beam.The fracture occurred at the beam connectors.There was abnormal laser cutting on the larger beam.The center of the beam appears to be almost completely removed with exception of a small raised portion.The failure mode is consistent with cyclic fatigue and final rupture due to ductile overload.The root cause of the fracture is likely the abnormal and narrow beams.
 
Event Description
It was reported that a guide wire break occurred.During this procedure a comet pressure guidewire was selected; however, after manipulation inside the lesion and some movement the pressure wire broke about 20cm from the distal end.An unspecified balloon was inflated which pressed the pressure wire against the vessel wall and they slowly removed everything from the lesion.The procedure was completed with another of the same device.No patient complications were reported.It was further reported that the vascular access was obtained via the right radial artery.The 75% stenosed, mildly calcified and mildly tortuous, 20mm in length target lesion was located in the left anterior descending artery.A 6fr guide catheter was advanced then this comet pressure guidewire was select.The patient was discharged the same day.
 
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Brand Name
COMET
Type of Device
TRANSDUCER, PRESSURE, CATHETER TIP
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8184052
MDR Text Key130986103
Report Number2134265-2018-64083
Device Sequence Number1
Product Code DXO
UDI-Device Identifier08714729904397
UDI-Public08714729904397
Combination Product (y/n)N
PMA/PMN Number
K151610
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 01/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/05/2019
Device Model Number8900
Device Catalogue Number8900
Device Lot Number0021218378
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/19/2018
Initial Date Manufacturer Received 12/07/2018
Initial Date FDA Received12/20/2018
Supplement Dates Manufacturer Received01/07/2019
Supplement Dates FDA Received01/29/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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