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)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/15/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a tip detachment occurred.A functional flow reserved (ffr) procedure was being performed.The target lesion was located in the tortuous and non calcified obtuse marginal (om) off of the circumfix.There were no previous devices inside of the om.This 185cm comet pressure guidewire was advanced to the lesion, they started performing ffr measurements, but they were unable to get a pressure reading.Fluoroscopy was used to see what may have been causing the issue, at this time the physician noticed that the radiopaque tip had separated from the body of the guidewire.They tried to pullback on the guidewire hoping that there was a small thread still connecting the two pieces, but they had completely separated.They proceeded to use wires and balloons to pull the guidewire tip back and ultimately, they needed to use a snare to remove the detached tip.The detached guidewire tip was retrieved and the procedure was completed with a different device.There were no adverse events to the patient.

• 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: 9672487
• Report Number: 2134265-2020-00861
• Device Sequence Number: 353874
• Product Code: DXO
• UDI-Device Identifier: 08714729875758
• UDI-Public: 08714729875758
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K151610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/05/2020

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: 09/29/2021
• Device Model Number: 8900
• Device Catalogue Number: 8900
• Device Lot Number: 0024517148
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 02/05/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR