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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 Communication or Transmission Problem (2896); Detachment of Device or Device Component (2907)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 02/07/2020
Event Type  Injury  
Manufacturer Narrative
Age at time of event: 18 years or older.
 
Event Description
It was reported that a tip detachment occurred.A percutaneous coronary intervention was being performed.Vascular access was obtained via the radial artery.The target lesion was located in the mid right coronary artery (rca).This comet pressure guidewire along with an entry needle were advanced to the target lesion.However, a tip detachment occurred.The detached tip was unable to be retrieved and was secured in the patient coronary vessel.The procedure was completed with another of the same device.No patient complications were reported.
 
Manufacturer Narrative
Age at time of event: 18 years or older.The devices shaft was visually and microscopically inspected for damage.The device showed 2 small bends located 16cm and 22cm from the separated distal end.The device showed a separation located 3.2cm from the tip.The total length of a comet wire is 185cm.The returned segment measured 181.8cm which means that 3.2cm was not returned.Functionality of the device could not be confirmed due to the damage of the device.The coefficient was confirmed to be programmed per specification.A material testing analysis and characterization was performed and identified that the proximal end showed that a fracture occurred at the beam location.Striations were present on the fractured surface which suggest reverse bending fatigue with possible ductile overload.Mechanical damage was also present at the final ruptured location and on some of the fractured surface.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.
 
Event Description
It was reported that a tip detachment occurred.A percutaneous coronary intervention was being performed.Vascular access was obtained via the radial artery.The target lesion was located in the mid right coronary artery (rca).This comet pressure guidewire along with an entry needle were advanced to the target lesion.However, a tip detachment occurred.The detached tip was unable to be retrieved and was secured in the patient coronary vessel.The procedure was completed with another of the same device.No patient complications were reported.It was further reported that the lesion was 95% stenosed and located in the tortuous and calcified, 25mm in length radial artery.The separation occurred after multiple attempts were made to cross the lesion.The break occurred 3cm from the tip and the tip became stuck in the lesion.At the time of the separation the guidewire had not prolapsed and had maintained position in the ostium during the entire procedure; however, the pressure signal was lost.
 
Manufacturer Narrative
Age at time of event: 18 years or older.
 
Event Description
It was reported that a tip detachment occurred.A percutaneous coronary intervention was being performed.Vascular access was obtained via the radial artery.The target lesion was located in the mid right coronary artery (rca).This comet pressure guidewire along with an entry needle were advanced to the target lesion.However, a tip detachment occurred.The detached tip was unable to be retrieved and was secured in the patient coronary vessel.The procedure was completed with another of the same device.No patient complications were reported.It was further reported that the lesion was 95% stenosed and located in the tortuous and calcified, 25mm in length radial artery.The separation occurred after multiple attempts were made to cross the lesion.The break occurred 3cm from the tip and the tip became stuck in the lesion.At the time of the separation the guidewire had not prolapsed and had maintained position in the ostium during the entire procedure; however, the pressure signal was lost.
 
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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 Key9733975
MDR Text Key180217299
Report Number2134265-2020-01498
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,foreig
Type of Report Initial,Followup,Followup
Report Date 04/16/2020
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 Date12/05/2021
Device Model Number8900
Device Catalogue Number8900
Device Lot Number0024889769
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/09/2020
Initial Date Manufacturer Received 02/07/2020
Initial Date FDA Received02/20/2020
Supplement Dates Manufacturer Received02/24/2020
03/31/2020
Supplement Dates FDA Received03/18/2020
04/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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