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

Model Number H7493932440

Device Problems Failure to Advance (2524); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/16/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by manufacturer ¿returned product consisted of a ffr comet wire separated into 2 segments.The proximal shaft and the tip were returned.The shaft was separated in 1 place.The total proximal shaft length that was returned was 152.5cm.The length of the tip portion returned was 33cm.There were also multiple kinks and bends throughout the length of the shaft.No other damage or irregularities were noticed.The sensor port was clear of any material.Functional testing of the device could not be completed due to the severe damage of the shaft.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

Reportable based on device analysis completed on april 6, 2017.It was reported that a catheter experienced difficulty advancing and a torque problem occurred.Ffr was performed in the 75% stenosis and tortuous circumflex (cx) artery using a comet¿ pressure guidwire.The device became difficult to advance into the periphery of the artery.Physician elected to continue use of the device.Eventually, the torque was not transmitted, so the device was removed to ensure safety.No patient complications were reported.However; returned device analysis revealed the shaft was separated in one place.

• 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: 6493023
• MDR Text Key: 72801736
• Report Number: 2134265-2017-03985
• Device Sequence Number: 1
• Product Code: DXO
• 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: 04/06/2017

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: 20139927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/06/2017
• Initial Date FDA Received: 04/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2134265
• Patient Sequence Number: 1