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

Model Number 2404-03

Device Problems Difficult to Remove (1528); Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Date 04/05/2021

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of an ffr comet pressure wire.The comet ii occ cable was not returned for analysis.The tip, device shaft, and sensor port were visually and microscopically examined for damage or any irregularities.Inspection of the device presented no damage or irregularities to the tip or body of the device.There was however fm (foreign material) at the end of the tip and protruding from the tip.Further investigation of the fm was performed through fourier-transform infrared spectroscopy (ftir) testing.The fm was removed from the end of the tip on the complaint device and placed on the ftir stage for analysis.Spectra was collected of the complaint device sample and presents similar peaks to that of a biological protein material.There was no evidence of any damage or irregularities contributing to the reported difficulty removing.Product analysis did not confirm the reported difficulty removing, as the clinical circumstances could not be replicated.However, the confirmed fm from the procedure on the end of the devices tip, indicates that there were difficulties removing the device.

Event Description

It was reported that difficulty removing a pressure guidewire occurred.A comet device was used for diastolic hyperemia free ratio (dfr) measurement at the right coronary artery (rca).Measurement was performed without problems, and a percutaneous coronary intervention (pci) was performed.It was noted that optical coherence tomography (oct) was used for imaging.Following stent placement, in order to perform dfr measurement, the comet device was pulled out to the rca ostium, where equalization was performed.The comet was then advanced to the periphery again, but the wire was trapped in the posterior descending artery and could not be removed.Percutaneous transluminal angioplasty (pta) by drug administration was performed and the comet was removed successfully by passing it through the microcatheter.After the device was removed, abnormality of the tip was observed.It was uncertain whether the coil was close or if the core had come out.There appeared to be a stretch, but the details were unknown.The device was not separated.It was noted that tissue appeared to be attached to the tip.The procedure was completed with this device.No further patient complications were reported in relation to this event.

• 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: 11735605
• MDR Text Key: 247710643
• Report Number: 2134265-2021-05304
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/27/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2022
• Device Model Number: 2404-03
• Device Catalogue Number: 2404-03
• Device Lot Number: 0026512560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2021
• Initial Date FDA Received: 04/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2020
• 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