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

Model Number 8900

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 04/09/2019

Event Type  Injury  

Event Description

It was reported via medwatch (b)(4) that a comet guide wire fractured occurred.The target lesion was located in the 60% stenosed, tortuous, and calcified left circumflex artery (lcx).This 185cm comet pressure guidewire along with a 3.5mm non-bsc guide catheter were advanced to first evaluate the left anterior descending artery.Then the comet pressure guidewire was advanced into the lcx, where fractional flow reserve (ffr) was completed.During removal there was minor prolapse of the comet pressure guidewire and tip became wedged in the calcified plaque.Three cm of the comet pressure guidewire tip became detached.Several attempts were made to snare the comet pressure guidewire tip, but decided to leave the detached tip since the patient was schedule for bypass surgery the following day.During the bypass surgery the comet guidewire tip was successfully removed.

• 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 SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 8707890
• MDR Text Key: 148299033
• Report Number: 2134265-2019-06876
• 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: 06/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/09/2020
• Device Model Number: 8900
• Device Catalogue Number: 8900
• Device Lot Number: 0022498396
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GUIDE CATHETER:XB 3.5 GUIDE
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 104