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

Device Problem Positioning Problem (3009)

Patient Problem Vascular Dissection (3160)

Event Date 05/26/2021

Event Type  Injury  

Event Description

It was reported a dissection occurred.A percutaneous coronary intervention (pci) procedure was being performed.Fractional flow reserve (ffr) was being performed with a comet ii pressure guidewire on the right diagonal (rd1) artery.The physician successfully placed the comet ii in the right posterolateral branch (rpld) and measured the ffr with 0.97.While repositioning the comet ii in the right interventricularis posterior (rivp), the wire suddenly showed a pressure of 350 mmhg.The physician flushed the wire, withdrew and replaced it.That did not help.The physician reconnected the wire with the ffr link without success.The decision was made to take a new comet ii.The measure in the rivp was fine with 0.96.After the first use of the wire in the right coronary artery (rca) the physician placed the new comet ii guidewire in the ramus interventricularis anterior (riva) artery.The measurement was fine, but the physician felt a loss of torque in the wire.This loss of torque was not improving.There was no chance to place the wire in the next vessel rd1.Then a third comet ii was used to measure the rd1.The physician encountered difficulty while attempting to torque the guidewire.After several attempts to manipulate the guidewire, the rd1 was dissected.The dissection was visible in the angiogram/cine.To treat the dissection, a non-bsc stent was implanted.The patient is fine after stent treatment.

• Brand Name: COMET II
• 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: 12000378
• MDR Text Key: 256240526
• Report Number: 2134265-2021-07632
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR