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

Model Number H7493932440

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/06/2017

Event Type  malfunction  

Manufacturer Narrative

Age at time of event is over 18.Device evaluated by manufacturer- inspection shows tip damage in the form bends.The shaft showed 2 kinks.The 1st kink was located at 59.5cm from the tip and the 2nd kink was located at 136cm from the tip.There was also some teflon coating peeled off approximately at 136cm from the tip.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause was unable to be determined.(b)(4).

Event Description

Reportable based on analysis completed on 11 august 2017.It was reported that the pressure arterial (pa) / pressure distal (pd) pressure was not stable.During a fractional flow reserve (ffr) a comet pressure wire was inserted in to the left anterior descending artery (lad).The physician flushed the comet with saline to equalize the pa/pd pressure.The pa/pd pressure failed to equalize and was unstable.After several unsuccessful attempts the comet was replaced with a new comet and the procedure was completed.No patient complications were reported.However; returned device analysis revealed teflon coating peeling.

• 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 (Section G): 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: 6840550
• MDR Text Key: 85013333
• Report Number: 2134265-2017-08593
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 08714729904403
• UDI-Public: (01)08714729904403(17)20171031(10)20248202
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 08/11/2017

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: 10/31/2017
• Device Model Number: H7493932440
• Device Catalogue Number: 393244
• Device Lot Number: 20248202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2017
• Initial Date FDA Received: 09/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2017
• 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