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 Consequences Or Impact To Patient (2199)
Date of Event	11/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: used (b)(6) 2019 as event date since the correct date was not provided.
Event or Problem Description
It was reported that a wire break occurred.Vascular access was obtained via the radial artery.The 70% stenosed lesion was located in the non tortuous and calcified, 20mm target lesion.This 185cm comet pressure guidewire was selected along with a opticross 6 imaging catheter which was loaded onto the comet wire and were delivered beyond the lesion.After imaging was performed and the opticross imaging catheter was withdrawn and the physician felt a "snap".Angiogram revealed that the comet wire had separated into two pieces in the proximal segment of the radiopaque tip.The physician retracted the comet wire and imaging catheter into the guide catheter as one unit.All parts of the wire were retrieved from the body.Another of the same device was used to completed the procedure.No patient complications were reported.

• 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: 9375731
• Report Number: 2134265-2019-14431
• Device Sequence Number: 11529772
• Product Code: DXO
• UDI-Device Identifier: 08714729875758
• UDI-Public: 08714729875758
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 11/26/2019

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 Model Number: 8900
• Device Catalogue Number: 8900
• Device Lot Number: 0024441322
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2019
• Initial Report FDA Received Date: 11/26/2019
• Patient Sequence Number: 1
• Patient Age: 55 YR