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

Model Number 8900

Device Problem Calibration Problem (2890)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/05/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr.: the product was returned to boston scientific for analysis.Returned product consisted of an fractionated flow reserve comet pressure wire connected to the optical cable.The tip, device shaft, sensor port and the coefficient values were examined for damage or any irregularities.The shaft showed 3 kinks located 33cm, 38cm and 136.5cm from the tip.The tip showed a bend and stretched coils.There was scraped coating at the 33cm location.The optical cable handle was connected to the fractionated flow reserve link to verify the signal strength.The signal was not present as designed.The coefficient was confirmed to be programmed.The optical cable 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.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.Device analysis determined the condition of the returned device was consistent with the reported information.

Event Description

Reportable based on analysis completed on 08jan2021.A comet pressure guidewire was being used for a procedure in the left anterior descending coronary artery.The guidewire was prepped in the usual fashion and inserted.The guidewire would not equalize within the acceptable deviation.The guidewire was removed and replaced with a second guidewire which equalized appropriately.No harm to the patient occurred.However, returned device analysis revealed scraped 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: 11229934
• MDR Text Key: 228681496
• Report Number: 2134265-2021-00729
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 08714729875758
• UDI-Public: 08714729875758
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/26/2021

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: 08/01/2022
• Device Model Number: 8900
• Device Catalogue Number: 8900
• Device Lot Number: 0025796958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/08/2021
• Initial Date FDA Received: 01/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 73 YR