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

Model Number H7493932430

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/05/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Returned product consisted of a ffr comet wire separated in two pieces.The guidewire shaft was examined for any damage or irregularities.It was noticed that the device was separated when returned.The proximal end of the shaft measured approximately 155.5cm.The distal end measured 29.5cm, 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 microscopy (sem) imaging and fractography was performed to measure the beam widths on the 1st through 7th rows adjacent to the proximal and distal fracture ends.Sem images revealed that one beam was observed to be relatively small and irregularly shaped compared to the opposed beam.The fracture face on the small beam was obscured by smeared metal so the original fracture features could not be determined.On the large fractured beam the features present were partially obscured by smeared metal but visible microscopic features included striations oriented radially and ductile dimples.These features would suggest that the beam had been subjected to some combination of cyclic straining and overloading or a series of tensile forces resulting in overload.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 right radial artery.The target lesion was located in a calcified left anterior descending artery (lad) with 60% stenosis and 5mm in length.Lad was a small vessel with some atherosclerosis and several turns.A comet pressure guidewire was advanced to the lesion.A non-bsc guidewire was placed as a buddy wire.The comet pressure guidewire was retracted without any problem to the left main and equalized.There was a turn in the vessel that was a little problematic passing with the comet pressure guidewire, but the wire was never stuck or bent more than the original bending of the tip.Distally 10cm of the comet pressure guidewire broke off inside the patient.The physician used no force or violence.The separation occurred during the manipulation of the comet pressure guidewire when passing a turn in the lad prior to the lesion.The separated portion of the wire was trapped using a balloon inside of a non-bsc guiding catheter.The balloon was inflated on the buddy wire within the guiding catheter and the wire was pulled out together with the guiding catheter successfully removing the remaining piece of the separated comet pressure guidewire.The patient was not harmed by this.The procedure was completed by using another comet pressure guidewire.No patient complications were reported and the patient is stable.

• 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: 7341653
• MDR Text Key: 102497132
• Report Number: 2134265-2018-01764
• 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: 02/15/2018

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: 10/24/2019
• Device Model Number: H7493932430
• Device Lot Number: 21296744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2018
• Initial Date FDA Received: 03/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2017
• 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
• Treatment: GUIDE CATHETER: MEDTRONIC GUIDE JCL 4,5; GUIDEWIRE: ASAHI SION BLUE
• Patient Outcome(s): Required Intervention