MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAWIRE DRIVE; CATHETER, CORONARY, ATHERECTOMY

Model Number 2077-01

Device Problem Device Damaged by Another Device (2915)

Patient Problems Cardiac Arrest (1762); Perforation (2001); Obstruction/Occlusion (2422)

Event Date 12/08/2022

Event Type  Death  

Event Description

It was reported that a patient death occurred.The patient was presented with aspiration pneumonia and required a hip surgery.Before having surgery, the patient's coronary artery disease was addressed.Vascular access was obtained via the femoral artery proactively with an unknown 4fr sheath.The 99% stenosed target lesion was located in the severely calcified containing a slight 70 degree bend located in the moderately tortuous trifurcation left anterior descending (lad) artery, 2nd diagonal and septal artery.A 1.50 rotapro burr, rotawire drive and a runway catheter guide were used during the procedure.The left main (lm), lad and circumflex artery (cfx) were all severely calcified with nodular and circumferential lesions throughout the cfx and lad.The cfx was engaged with a non-boston scientific guidewire advanced in a non-boston scientific microcatheter.The wire was removed and a rotawire drive was advanced down the circumflex.The 1.5 rotapro burr was prepped and tested outside the body with speed platformed at 160,000 revolution per minute (rpm).The burr was advanced over the wire to the distal edge of the guide and was then tested again within the body and with the speed continuing to be 160,000 rpm.The atherectomy of the cfx artery was started and there was a large nodule of calcium at the distal lm into the cfx ostium.A couple of runs were made focusing only on cfx ostium with the run times not exceeding 18 seconds.Next, there were a few more runs focusing on the mid cfx lesion that had an om 1 just proximal to lesion with the run times not exceeding 18 seconds as well.After the atherectomy was performed, the burr was removed via dynaglide mode and the microcatheter was backloaded over the rotawire.Then the guidewire was inserted back into the microcatheter, and a non-boston scientific balloon was used to trap out the microcatheter.Next, another non-boston scientific balloon was used to pre-dilate the circumflex lesion.With the lesion yielding correctly in the circumflex, the wire was pulled back and navigated down the lad.The microcatheter was then backloaded over the wire and floated into the guide until the wire came out from the back end of the microcatheter.The microcatheter was then spun and advanced where the burr had stalled in the mid lad at a trifurcation until it could not advance anymore.With the microcatheter tip engaged in the lesion, the wire was removed and a new rotawire drive was advanced into the microcatheter and down the lad.The microcatheter was removed from the rotawire drive and the 1.5 rotapro burr was then backloaded over the wire to the distal end of the guide.A platform speed was then check again once burr was at the tip of the guide catheter and noted at 160,000rpm.At this point, the physician started the atherectomy focusing on the proximal aspect of the lad for a couple runs for less than 18 seconds.After the physician felt comfortable ablating the proximal aspect of the lad, the device was moved on to the mid aspect of the lad where there was a trifurcation and the same area the microcatheter did not cross.After 7 to 8 runs for no longer than 30 seconds in duration, the final run of the burr jumped across the mid lad and stalled out.The physician then started to advance the rotawire drive while pulling back on the burr advancer and the burr popped back across the mid lesion.A final run was attempted before removing burr.On final run, the burr was turned on and slowly advanced though it was not traveling in the same direction of lad and seemed to follow path of the 1st diagonal.The burr was immediately turned off and was removed from the wire.When the 1.5 burr came out of the hemostatic valve, there was no wire indicating that the wire had been fractured.An angiography was obtained confirming that the tip of the wire was still in the distal lad and at the trifurcation lesion showed a dissection/perforation that was occluding from the mid lad to the apex.The physician sized up the sheath to a 9fr and inserted a non-boston scientific intra-aortic balloon.The device was then attempted to recross the lad dissection with the wire with no success.Use of a polymer jacketed wire was attempted without success.A pericardiocentesis was performed until the patient experience cardiac arrest and passed away.

• Brand Name: ROTAWIRE DRIVE
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16091498
• MDR Text Key: 306569265
• Report Number: 2124215-2022-55262
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P900056/S166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/03/2023

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 Model Number: 2077-01
• Device Catalogue Number: 2077-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2022
• Initial Date FDA Received: 01/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death