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

Model Number	8900
Medical Device Problem Codes	Communication or Transmission Problem (2896); Detachment of Device or Device Component (2907); Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/23/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a tip detachment occurred.A fractional flow reserve (ffr) procedure was being performed.Vascular access was obtained via the right radial artery.This comet pressure guidewire was selected and ffr was successfully performed in the right coronary artery.They attempted to perform another diagnosis in the left anterior descending artery; however, there was difficulty crossing the very narrow and tortuous lesion.Once they were able to cross the lesion they noticed that the signal was lost and measurements were unable to be completed.During withdrawal they noticed that a separation occurred inside the sleeve approximately 3cm from the distal tip.They managed to retrieve the complete length of the wire from the patient.It was noted that the device became kinked as some point during the procedure.The procedure was completed with another of the same device.No patient complications were reported and the patients status is perfect.
Event or Problem Description
It was reported that a tip detachment occurred.A fractional flow reserve (ffr) procedure was being performed.Vascular access was obtained via the right radial artery.This comet pressure guidewire was selected and ffr was successfully performed in the right coronary artery.They attempted to perform another diagnosis in the left anterior descending artery; however, there was difficulty crossing the very narrow and tortuous lesion.Once they were able to cross the lesion they noticed that the signal was lost and measurements were unable to be completed.During withdrawal they noticed that a separation occurred inside the sleeve approximately 3cm from the distal tip.They managed to retrieve the complete length of the wire from the patient.It was noted that the device became kinked as some point during the procedure.The procedure was completed with another of the same device.No patient complications were reported and the patients status is perfect.
Additional Manufacturer Narrative
Device evaluated by mfr:the shaft of the returned device was visually and microscopically inspected for damage.The device showed a separation located 3cm from the tip.The total wire (185cm) was returned and accounted for.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 kinks and bends throughout the wire length.A scanning electron microscopy examination was performed which identified distal end failure, post failure damage, striations, and dimpling at the center support.The proximal end identified post failure damage, striations, and a raised center line.This type of damage may have been caused by reverse bending fatigue with possible ductile overload which is indicative of failures in the slotted tube region.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.

• 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: 10120801
• Report Number: 2134265-2020-06992
• Device Sequence Number: 13989005
• Product Code: DXO
• UDI-Device Identifier: 08714729904397
• UDI-Public: 08714729904397
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K151610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/05/2022
• Device Model Number: 8900
• Device Catalogue Number: 8900
• Device Lot Number: 0025308981
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2020
• Initial Date Received by Manufacturer: 05/25/2020
• Supplement Date Received by Manufacturer: 07/20/2020
• Initial Report FDA Received Date: 06/04/2020
• Supplement Report FDA Received Date: 07/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Weight: 74