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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION COMET II; TRANSDUCER, PRESSURE, CATHETER TIP
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BOSTON SCIENTIFIC CORPORATION COMET II; TRANSDUCER, PRESSURE, CATHETER TIP Back to Search Results
Model Number 2404-01
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 01/26/2021
Event Type  Injury  
Event Description
It was reported that tip detachment occurred.A percutaneous coronary intervention (pci) was performed on a patient with coronary artery disease (cad).The target lesion was located in the right coronary artery (rca).A comet guidewire was advanced to the rca to take a diastolic hyperemia free ratio (dfr) measurement.Upon completion of the dfr, an high definition (hd) intravascular ultrasound (ivus) catheter was inserted over the wire to assess whether a lesion was present proximal to the previously placed stent.It was determined that no further intervention was needed.The hd ivus catheter was removed and the comet wire ended up getting pulled back out of the ivus catheter.It was observed that the distal platinum coil was not present on the wire when it was removed.The guide was flushed to see if was in there, but was not found.The patient was scanned twice to see if the tip was visible in the rca or other areas it could have migrated to, but nothing was seen.Since the wire tip was not found, the physician decided to complete the case.The procedure was successfully completed and the patient was reported to be stable.A subsequent ct scan of the chest and neck area did not reveal a wire fragment.No patient complications were reported in relation to this event.
 
Manufacturer Narrative
Returned product consisted of the proximal portion of the ffr comet pressure wire.The distal portion of the wire and the occ cable were not returned for analysis.The device shaft that was returned was visually and microscopically examined.Inspection of the device revealed that the shaft was separated at the distal end.The distal end was bent, indicating that it was likely that tensile force was applied, and the shaft kinked prior to separation.The portion of the returned wire was measured and found to be 175cm from the proximal end to the separation.Indicating that 10 +/- 5cm of the shaft with the tip was detached.Materials, testing, analysis and characterization (mtac) results found that the failure occurred in one beam and through one ring near the same plane, for a total of three fracture faces.All appeared consistent with ductile overload, with no obvious abnormalities (size, shape, surface features).It is hypothesized the distal portion was fixed/stuck while the device was being pushed and/or torqued, leading to the slight kink and the failure.
 
Event Description
It was reported that tip detachment occurred.A percutaneous coronary intervention (pci) was performed on a patient with coronary artery disease (cad).The target lesion was located in the right coronary artery (rca).A comet guidewire was advanced to the rca to take a diastolic hyperemia free ration (dfr) measurement.Upon completion of the dfr, an high definition (hd) intravascular ultrasound (ivus) catheter was inserted over the wire to assess whether a lesion was present proximal to the previously placed stent.It was determined that no further intervention was needed.The hd ivus catheter was removed and the comet wire ended up getting pulled back out of the ivus catheter.It was observed that the distal platinum coil was not present on the wire when it was removed.The guide was flushed to see if was in there, but was not found.The patient was scanned twice to see if the tip was visible in the rca or other areas it could have migrated to, but nothing was seen.Sine the wire tip was not found, the physician decided to complete the case.The procedure was successfully completed and the patient was reported to be stable.A subsequent ct scan of the chest and neck area did not reveal a wire fragment.No patient complications were reported in relation to this event.It was further reported that vascular access was obtained via the radial artery.The 50% stenosed target lesion was located in the rca and this was the first vessel treated.It was noted that there was no abnormal anatomy noted.A 6 french catheter was used during the procedure.The separation occurred with the ivus was being removed from the wire.The ivus hd catheter was tracked over the wire during the procedure.It was noted that it appeared that the 3cm coil detached.The wire did not prolapse or kink.The wire did not get trapped at any point during the procedure.The tip of the catheter maintained position in the ostium during the entire procedure.It was noted that the wire tip was not visible in the artery or body.Multiple scans were taken to see if the tip migrated.Not all parts of the wire were retrieved from the patient body.There were no difficulties or abnormalities when shaping the tip.There were no issues encountered with crossing the lesion.It was noted that the ivus catheter pulled back over the wire.When the catheter was removed, it was not on the wire.It was noted that it was possible that the monorail portion of the ivus catheter could have ripped the tip of the wire off when it was pulled back.No patient complications were reported in relation to this event.
 
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Brand Name
COMET II
Type of Device
TRANSDUCER, PRESSURE, CATHETER TIP
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key11341278
MDR Text Key232330935
Report Number2134265-2021-01827
Device Sequence Number1
Product Code DXO
UDI-Device Identifier08714729960140
UDI-Public08714729960140
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 03/10/2021
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 Date10/20/2022
Device Model Number2404-01
Device Catalogue Number2404-01
Device Lot Number0026215424
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/08/2021
Initial Date Manufacturer Received 01/26/2021
Initial Date FDA Received02/17/2021
Supplement Dates Manufacturer Received02/17/2021
Supplement Dates FDA Received03/10/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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