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

Model Number 8900

Device Problems Failure to Advance (2524); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/18/2019

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older device evaluated by mfr: the tip, device shaft, sensor port and the coefficient values were examined for damage or any irregularities.The shaft showed 2 kinks located at the occ handle and 177.5cm from the tip.There was coating peeling from the 177.5 location.The occ handle was connected to the ffr link for signal verification.The signal was present as designed.The occ handle cap was loosened to remove the wire.There was no issue with removing the wire.The sensor port showed no residue of body fluids.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The complaint of a kink was confirmed.The pressure wire was connected to the analysis support test bench and all applicable data was correct as designed, there was no difficulty in connecting the wire to the test equipment.The coefficient was confirmed to be in specification.

Event Description

It was reported that difficulty crossing the lesion and a torque problem occurred.The 90% stenosed target lesion was located in the tortuous distal right coronary artery (rca).A comet pressure guidewire was used but was unable to cross the tortuous area in the mid rca.It was noticed that the torque could not be managed at all.The procedure was completed with a non bsc device that was able to cross the lesion.No patient complications were reported in relation to this event.However, returned device analysis revealed peeled coating.

• 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 SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 8902226
• MDR Text Key: 154582245
• Report Number: 2134265-2019-09313
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 08714729904403
• UDI-Public: 08714729904403
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K151610
• 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: 08/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/10/2021
• Device Model Number: 8900
• Device Catalogue Number: 8900
• Device Lot Number: 0023329820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2019
• 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