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 Consequences Or Impact To Patient (2199)

Event Date 10/15/2019

Event Type  malfunction  

Event Description

It was reported that a tip separation occurred.Vascular access was obtained via the right radial artery.A comet pressure guidewire was used to treat several vessels during an ffr.The comet was advanced to the left anterior descending artery (lad), then the diagonal branch, and lastly the circumflex artery (cx).The wire was reshaped several times after use in the different vessels.It was noted that the tip of the wire had become trapped while advancing through the left main artery (lm).It was also noted that a kink or prolapse had been observed.The wire was removed without complications.After the wire was removed and outside the patient, the wire was bent several times to reshape, but broke.It was noted that the separation occurred 1.5 cm from the tip of the wire.The procedure was completed with another of the same device.No patient complications resulted in relation to this event and the patient was reported to be okay following the procedure.

• 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: 9342749
• MDR Text Key: 169133616
• Report Number: 2134265-2019-14072
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 08714729904397
• UDI-Public: 08714729904397
• Combination Product (y/n): N
• Reporter Country Code: NO
• 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: 11/19/2019

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: 0024333947
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2019
• Initial Date FDA Received: 11/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1