MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE COMET; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number H7495551110

Device Problem Calibration Problem (2890)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/22/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4)/ device evaluated by mfr: returned product consisted of a ffr comet pressure wire in one piece.The shaft was kinked at approximately 124cm from the tip.The device had multiple bends on the shaft.The shaft also showed some teflon scrapping approximately 124cm from the tip.Blood was noticed in the sensor port.No other damage was noticed.Upon connecting the device to the analysis support test bench it was noticed that the coefficient values were not present.This is an indication of the rfid tag not being programmed.The complaint of difficult/unable to recognize zero was confirmed due to the coefficient values not being present.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause has been determined to be manufacturing related.(b)(4).

Event Description

Reportable based on analysis completed november 16, 2016 it was reported that the pressure wire was unable to equalize.A comet pressure wire was connected to the ffr link.The staff was able to zero ao pressure, but was unable to equalize on the polaris ffr system.The polaris system was trouble shot with no improvement.A new comet wire was opened, successfully zero'd, equalized and was able to be used to perform ffr.No patient complications were reported.Returned device analysis revealed teflon scrapping.

• Brand Name: COMET
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6155472
• MDR Text Key: 61893668
• Report Number: 2134265-2016-11219
• Device Sequence Number: 1
• Product Code: DXO
• 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: Health Professional
• Type of Report: Initial
• Report Date: 11/16/2016

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: 10/28/2017
• Device Model Number: H7495551110
• Device Lot Number: 19258066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2016
• Initial Date FDA Received: 12/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2016
• 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