MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION COMET; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number	8900
Medical Device Problem Codes	Failure to Advance (2524); Communication or Transmission Problem (2896); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/24/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a tip detachment occurred.A percutaneous coronary intervention was being performed.Vascular access was obtained via a femoral approach.The 90% stenosed target lesion was located in the severely tortuous and severely calcified distal right coronary artery.A non bsc guide catheter and this comet pressure guidewire were selected.During advancement torque was applied at the tortuous portion of the lesion, the device was able to advance but was not unable to cross the lesion.They attempted to remove and insert the device several times, but they were still unable to cross the lesion.When the device was removed again, it was noticed that the opaque tip did not move the same and the pd value had disappeared on the polaris system.At this time, they found that a separation occurred near the pressure sensor and laser cut portion.Negative pressure was applied to the guide catheter with a syringe, and the separated part was able to be pulled back into the guide catheter.A 1.75 non-bsc balloon catheter was then used to trap and remove the separated tip.No patient complications were reported; however, due to the amount of exposure and prolonged procedure time the procedure was not completed.
Additional Manufacturer Narrative
Device evaluated by mfr: the comet pressure wire was returned with only the proximal end of the wire.Device analysis identified that the wire was separated 2.5cm from the tip.The total wire length is 185cm, the total wire length returned was 182.5cm.Functionality of the device could not be confirmed due to the damage of the device.The coefficient was confirmed to be programmed per specification.The device showed a slight bend located 32.5cm from the tip.Materials testing analysis & characterization images identified that the fractured beams and cracking of the adjacent slots appear to be consistent with reverse bending fatigue failure.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The complaint of device separation was confirmed.Device analysis determined the condition of the returned device was consistent with the reported information.
Event or Problem Description
It was reported that a tip detachment occurred.A percutaneous coronary intervention was being performed.Vascular access was obtained via a femoral approach.The 90% stenosed target lesion was located in the severely tortuous and severely calcified distal right coronary artery.A non bsc guide catheter and this comet pressure guidewire were selected.During advancement torque was applied at the tortuous portion of the lesion, the device was able to advance but was not unable to cross the lesion.They attempted to remove and insert the device several times, but they were still unable to cross the lesion.When the device was removed again, it was noticed that the opaque tip did not move the same and the pd value had disappeared on the polaris system.At this time, they found that a separation occurred near the pressure sensor and laser cut portion.Negative pressure was applied to the guide catheter with a syringe, and the separated part was able to be pulled back into the guide catheter.A 1.75 non-bsc balloon catheter was then used to trap and remove the separated tip.No patient complications were reported; however, due to the amount of exposure and prolonged procedure time the procedure was not completed.

• Brand Name: COMET
• Common Device Name: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10271806
• Report Number: 2134265-2020-08607
• Device Sequence Number: 811060
• Product Code: DXO
• UDI-Device Identifier: 08714729904403
• UDI-Public: 08714729904403
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/16/2022
• Device Model Number: 8900
• Device Catalogue Number: 8900
• Device Lot Number: 0025062757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2020
• Initial Date Received by Manufacturer: 06/24/2020
• Supplement Date Received by Manufacturer: 08/18/2020
• Initial Report FDA Received Date: 07/14/2020
• Supplement Report FDA Received Date: 09/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention