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

Model Number 8900

Device Problems Communication or Transmission Problem (2896); Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 01/15/2020

Event Type  Injury  

Event 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
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9672487
• MDR Text Key: 177855760
• Report Number: 2134265-2020-00861
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 08714729875758
• UDI-Public: 08714729875758
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR