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

Model Number H7493932430

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/21/2016

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: the guidewire was completely separated 15cm from the distal tip.The proximal fracture to the seam weld was 23cm.There also was a bend at 13cm from the proximal break on the wire.The magnified inspection of the fractured surface appears to be consistent with separation due to ductile bending overload.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical/procedural factors.(b)(4).

Event Description

It was reported that the pressure guidewire broke.The comet pressure wired had been used to obtain an ffr measurement in the left circumflex (lcx) artery.During withdrawal of the wire into the guide catheter in preparation for performing an ffr measurement in the left anterior descending (lad) artery, the operator felt no response with the wire.The wire as locked in a kink of the guide catheter at the level of the subclavian artery.When the operator withdrew the comet wire and guide catheter outside the patient, the guide catheter was twisted at 20cm from the distal tip and the comet wire separated in two pieces at the level of the guide catheter kink.The ffr measurement in the lad was performed with a new comet wire.No patient complications were reported.

• 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5591401
• MDR Text Key: 43179057
• Report Number: 2134265-2016-03141
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: NA
• 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: 03/22/2016

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: 11/30/2016
• Device Model Number: H7493932430
• Device Lot Number: 18928747
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2016
• Initial Date FDA Received: 04/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1