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

Model Number	8900
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/09/2019
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8707890
• Report Number: 2134265-2019-06876
• Device Sequence Number: 16666976
• Product Code: DXO
• UDI-Device Identifier: 08714729875758
• UDI-Public: 08714729875758
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 06/18/2019

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: 08/09/2020
• Device Model Number: 8900
• Device Catalogue Number: 8900
• Device Lot Number: 0022498396
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2019
• Initial Report FDA Received Date: 06/18/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER:XB 3.5 GUIDE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Weight: 104