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

Model Number 8900

Device Problems Fracture (1260); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/08/2019

Event Type  malfunction  

Event Description

It was reported that a wire fracture occurred.Vascular access was obtained via the radial artery.The first 185cm comet pressure wire was selected and was advanced through a 6fr non bsc guide catheter.The first vessel that was evaluated, without any issues, was the right coronary artery.They decided to evaluate the proximal left anterior descending artery (lad); however, the comet wire was catching inside the non bsc guide catheter and appeared "fractured" 3 cm proximal from the distal tip as it emerged from the non bsc guide catheter.The comet wire did not separate and was removed intact.A 2nd 185cm comet pressure wire was selected and used with the same 6fr non bsc guide catheter.The 2nd comet wire was noted to be bent prior to use.During use of the 2nd comet wire, it also was noted to be catching inside the non bsc guide catheter and emerged from the guide appearing fractured in the same approximate location.The 2nd comet wire was removed intact as well.The procedure was completed with another of the same device.There were no patient complications.

• 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: 9410044
• MDR Text Key: 175659803
• Report Number: 2134265-2019-14429
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 08714729904397
• UDI-Public: 08714729904397
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K151610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/04/2019

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
• Device Operator: Health Professional
• Device Model Number: 8900
• Device Catalogue Number: 8900
• Device Lot Number: 0024383659
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2019
• Initial Date FDA Received: 12/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1