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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION COMET II; TRANSDUCER, PRESSURE, CATHETER TIP
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BOSTON SCIENTIFIC CORPORATION COMET II; TRANSDUCER, PRESSURE, CATHETER TIP Back to Search Results
Model Number 2404-03
Device Problems Material Integrity Problem (2978); Positioning Problem (3009)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/27/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that peeled coating and difficulty advancing a guidewire occurred.After shaping the tip of a comet ii pressure guidewire with an inserter, it was observed that the coating was peeled off.It was noted that it appeared to be lifted (outside the patient), and after that, maneuverability became worse.The procedure was completed with another of the same device.No patient complications resulted in relation to this event.It was further reported that the inserter was pressed against the distal part of the wire and the inserter slid to the distal tip of the wire.It was considered that the coating was peeled due to friction between the wire and the inserter.It was clarified that the worsened maneuverability meant that the torque force was not transmitted well.No patient complications were reported in relation to this event.
 
Event Description
It was reported that peeled coating and difficulty advancing a guidewire occurred.After shaping the tip of a comet ii pressure guidewire with an inserter, it was observed that the coating was peeled off.It was noted that it appeared to be lifted (outside the patient), and after that, maneuverability became worse.The procedure was completed with another of the same device.No patient complications resulted in relation to this event.It was further reported that the inserter was pressed against the distal part of the wire and the inserter slid to the distal tip of the wire.It was considered that the coating was peeled due to friction between the wire and the inserter.It was clarified that the worsened maneuverability meant that the torque force was not transmitted well.No patient complications were reported in relation to this event.
 
Manufacturer Narrative
E1: initial reporter address: (b)(6).Device evaluated by mfr.: the product was returned to boston scientific for analysis.Returned product consisted of an fractional flow reserve comet pressure wire.No ffr optical cable handle was returned.The tip, device shaft and sensor port were examined for damage or any irregularities.It was noticed that the guidewire insertion tool that was sent with the guidewire was on the wire approximately located at 150cm from the tip.The shaft showed multiple bends and kinks along the shaft.The tip showed bend damage.Per the reported complaint the shaft was inspected for coating being peeled or scraped off the wire shaft.It was noticed that a section of the wire showed scrapped off coating.The coating damage was approximately 153cm from the tip.Since the original optical cable handle was not returned a test optical cable handle was used for testing purposes.The test optical cable was connected to the fractional flow reserve link for signal verification.The signal was not present as designed.Device analysis was conducted by inspecting the proximal end of the wire for any damage to the fiber optic.No damage was noticed.The sensor was inspected by viewing the sensor port to verify that the sensor was in the correct location.This sensor looked to be too far distal which would give the indication of the sensor being detached from the fiber optic cable.The wire was gently shaken to see if the sensor would move within the sensor housing and the sensor did move which verified the sensor was detached from the fiber optic.The sensor housing showed residue of body fluids.Device analysis determined the condition of the returned device was consistent with the reported information of a pressure issue.The reported complaint of a coating issue was confirmed.
 
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Brand Name
COMET II
Type of Device
TRANSDUCER, PRESSURE, CATHETER TIP
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key10976924
MDR Text Key220486297
Report Number2134265-2020-16871
Device Sequence Number1
Product Code DXO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 01/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/28/2022
Device Model Number2404-03
Device Catalogue Number2404-03
Device Lot Number0026259882
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/21/2020
Date Manufacturer Received01/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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