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

Model Number H7493932440

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/26/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: returned product consisted of a ffr comet wire separated in two pieces.The guidewire shaft was examined for any damage or irregularities.The proximal end of the shaft measured approximately 164cm.The distal end measured 21cm, which equaled 185cm.The total length of a complete comet wire is 185cm.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage.The sensor port showed evidence of blood.Functional testing of the device could not be completed due to the separation of the shaft.Scanning electron microsopy (sem) imaging and fractography was performed to measure the beam widths on 7 rows adjacent to the proximal and distal fracture ends.One beam was observed to be relatively small and the other was irregularly shaped.The fracture faces were obscured by smeared metal so the original fracture features could not entirely be determined.On the relatively small or narrow beam visible microscopic features of striations oriented radially were present.The direction of the smeared metal was consistent to what is seen with a doctor ¿spinning¿ the device.These features would suggest that the beam had been subjected to cyclic straining.It was noticed that the beams were narrow on the device which contributed to the failure of the wire, therefore the investigation conclusion is manufacturing execution error as the manufacturing process was not executed as validated/as designed.(b)(4).

Event Description

It was reported that guidewire separation occurred.Vascular access was obtained via the left radial artery.Target lesion was located in a non calcified left anterior descending artery (lad).There was no severe tortuosity through the approach route and no difficulty for engaging the 5f diagnostic catheter.After the comet pressure guidewire went through a tortuous portion at the proximal lad, the physician tried to deliver the wire to the distal lad.The distal end of the comet wire went through a side branch.When the physician tried to withdraw the comet wire to the lad, loss of torque occurred and the distal portion of the comet wire did not move.The physician examined x-ray image and found the wire separated at the second curve of the diagnostic catheter.The wire was separated 21cm from the distal tip.The physician inflated a balloon inside the catheter to push the wire against the catheter wall.All devices were removed together.No fragment remained in the patient and the fractional flow reserve (ffr) procedure was aborted.No patient complications were reported and the patient is fine.

• 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: 7341823
• MDR Text Key: 102495615
• Report Number: 2134265-2018-01999
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/13/2019
• Device Model Number: H7493932440
• Device Catalogue Number: 393244
• Device Lot Number: 21378261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2018
• Initial Date FDA Received: 03/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: JL4.0 5FR DIAGNOSTIC CATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR