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

Model Number 8900

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/10/2019

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 located 157cm and 175cm from the tip.The tip showed damage in the form of bends.There was some peeled coating at the kinked locations.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 housing showed no residue of body fluids.The wire was inserted into the pressure chamber test equipment and the pressure was increased to verify the sensor was indeed reacting to the pressure increases and decreases.The pressure sensor functioned as designed.The coefficient was confirmed to be in specification.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.Because there was no evidence of any product quality deficiencies, it was considered likely that the kinks, tip damage and peeled coating were attributable to handling.

Event Description

Reportable based on analysis completed on 08 nov 2019.It was reported that recognition failure occurred.A coronary angiogram was being performed on a mildly calcified and moderately tortuous lesion in a coronary artery.While using the comet pressure guidewire, recognition failure occurred during prep.The procedure was successfully completed with a different device without issue or patient injury.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: 9380354
• MDR Text Key: 173946270
• Report Number: 2134265-2019-14333
• 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: 11/26/2019

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: 05/08/2021
• Device Model Number: 8900
• Device Catalogue Number: 8900
• Device Lot Number: 0023764281
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2019
• Initial Date FDA Received: 11/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2019
• 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