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

Model Number H7495551110

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/19/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the guide wire fractured.Vascular access was obtained via the right femoral artery.Fractional flow reserve (ffr) was attempted in the 40-50% stenosis with a 8-12 mm long lesion in a non-tortuous left anterior descending artery (lad) using a comet¿ pressure guidewire.The insertion of comet to the lad was attempted using a non-bsc guide catheter but the wire was just not tracking down the lad.The physician removed the comet¿ from the patient¿s body and was attempting to re-shape wire tip when the wire broke in the physician¿s hand.The scrub tech held up the comet¿ and estimated the device broke approximately 6 inches from the distal tip.The case was successfully completed with a new comet¿.No report of patient complications.

Manufacturer Narrative

Device evaluated by manufacturer: returned product consisted of a comet wire separated into 2 segments.The proximal shaft and the distal portion were returned.The shaft was separated in 1 place.The total proximal shaft length that was returned was 155cm.The length of the distal portion returned was 30cm which equals 185cm.The tip had a slight bend to it, most likely from the shaping from the physician.The sensor port was clear.Functional testing of the device could not be completed due to the separation of the shaft.Scanning electron microscopy (sem) analysis showed 1st row adjacent to distal end of fracture, likely resulted from an etching process and not wire separation.Some ductile dimple surface was observed on both distal and proximal wire separation.Overview sem images of distal and proximal ends of fracture indicate a bend overload failure.The fracture occurred approximately 30 cm from distal 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

It was reported that the guide wire fractured.Vascular access was obtained via the right femoral artery.Fractional flow reserve (ffr) was attempted in the 40-50% stenosis with a 8-12 mm long lesion in a non-tortuous left anterior descending artery (lad) using a comet¿ pressure guidewire.The insertion of comet to the lad was attempted using a non-bsc guide catheter but the wire was just not tracking down the lad.The physician removed the comet¿ from the patient¿s body and was attempting to re-shape wire tip when the wire broke in the physician¿s hand.The scrub tech held up the comet¿ and estimated the device broke approximately 6 inches from the distal tip.The case was successfully completed with a new comet¿.No report of patient complications.

• 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: 6677121
• MDR Text Key: 78700850
• Report Number: 2134265-2017-06652
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 06/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/05/2019
• Device Model Number: H7495551110
• Device Lot Number: 0020607412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2017
• 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
• Patient Age: 88 YR