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

Model Number 8900

Device Problem Failure to Zero (1683)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/04/2019

Event Type  malfunction  

Manufacturer Narrative

Returned product consisted of an ffr comet pressure wire connected to the occ cable.The tip, device shaft, sensor port and the coefficient values were examined for damage or any irregularities.The shaft showed 2 kinks.The kinks were located at 32.5cm and 38cm from the tip.The tip showed bend damage.There was coating peeled at the 32.5cm location.The occ handle was connected to the ffr link for signal verification.The signal was not present as designed.The occ handle cap was loosened to remove the wire.There was no issue with removing the wire.A known good occ handle was used to verify cable operation was correct with the returned occ.The test occ cable and the connected returned wire functioned as designed.The returned cable was dissected to check the fep disk for damage.It was noticed that the fep disk was damaged where the wire seats against the disk.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 coefficient was confirmed to be in specification.Because there was no evidence of any product quality deficiencies, it was considered likely that the shaft damage, tip damage and the peeled coating damage were attributable to handling issues.

Event Description

Reportable based on analysis completed on 18nov2019.During a coronary angiogram, a comet pressure guidewire was selected to perform a fractional flow reserve study.The comet pressure guidewire was prepared as per the dfu and connected to the ffr link; however, the comet pressure guidewire failed to zero.The comet was disconnected and reattached a number of times; however, the result was the same.Another comet pressure guidewire was opened and used without any issue.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 CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9410986
• MDR Text Key: 175078510
• Report Number: 2134265-2019-14806
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 08714729904397
• UDI-Public: 08714729904397
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 12/04/2019

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 Expiration Date: 11/15/2020
• Device Model Number: 8900
• Device Catalogue Number: 8900
• Device Lot Number: 0022948336
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2019
• Initial Date FDA Received: 12/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2018
• 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