MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAWIRE AND WIRECLIP TORQUER; CATHETER, CORONARY, ATHERECTOMY

Model Number 3520

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Hematoma (1884); Perforation of Vessels (2135)

Event Date 12/17/2021

Event Type  Death  

Manufacturer Narrative

Initial reporter facility name - (b)(6).

Event Description

It was reported that perforation and death occurred.A rotapro 1.50mm over a rotawire floppy were selected to treat a significantly calcified diffuse lesion in the proximal to mid left anterior ascending artery (lad) vessel.Rotablation was successfully performed with multiple runs.The burr was then advanced to the lesion within the mid lad near the bifurcation of the 1st diagonal artery.Reviewing the stored fluoroscopy it appeared that the burr was pecking at the lesion, and then the burr advanced rapidly along the wire with little control.The rota burr then deaccelerated and stalled instantaneously.Upon activation of rotablation, the system continued to stall.On selection of dynaglide, the system again stalled.The physician, however was able to remove the burr from the patient with a retracting pull on the sheath.During fluoroscopy and injection of contrast a perforation was identified within the mid lad at the location of the calcified lesion.The rotawire was exchanged and a balloon was inflated at the point of the perforation to minimize the bleeding in the pericardial space.Ivus was used to image the vessel and a hematoma was visible.Two drug eluting stents were implanted from prox lad to mid lad.Pericardiocentesis was performed and an aortic balloon pump was inserted.The patient then went into a cardiac arrest and cpr was performed on table.The patient then stabilized, although in a critical condition was transferred to the intensive care unit.The patient later died from the complications experienced in the procedure.

Manufacturer Narrative

E1: initial reporter state - (b)(6).

Event Description

It was reported that perforation and death occurred.A rotapro 1.50mm over a rotawire floppy were selected to treat a significantly calcified diffuse lesion in the proximal to mid left anterior ascending artery (lad) vessel.Rotablation was successfully performed with multiple runs.The burr was then advanced to the lesion within the mid lad near the bifurcation of the 1st diagonal artery.Reviewing the stored fluoroscopy it appeared that the burr was pecking at the lesion, and then the burr advanced rapidly along the wire with little control.The rota burr then deaccelerated and stalled instantaneously.Upon activation of rotablation, the system continued to stall.On selection of dynaglide, the system again stalled.The physician, however was able to remove the burr from the patient with a retracting pull on the sheath.During fluoroscopy and injection of contrast a perforation was identified within the mid lad at the location of the calcified lesion.The rotawire was exchanged and a balloon was inflated at the point of the perforation to minimize the bleeding in the pericardial space.Ivus was used to image the vessel and a hematoma was visible.Two drug eluting stents were implanted from prox lad to mid lad.Pericardiocentesis was performed and an aortic balloon pump was inserted.The patient then went into a cardiac arrest and cpr was performed on table.The patient then stabilized, although in a critical condition was transferred to the intensive care unit.The patient later died from the complications experienced in the procedure.It was further reported that a significantly stenosed target lesion was located in the moderately tortuous and significantly calcified the proximal to mid left anterior ascending artery (lad) vessel.The rotational speed was at 160,000rpm.The patient was present with symptomatic angina for the original procedure.The physician's opinion as to the cause of the perforation was that the rotapro burr advanced around tortuosity, uncontrollable advancement of burr, and the burr stalled.

• Brand Name: ROTAWIRE AND WIRECLIP TORQUER
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13102268
• MDR Text Key: 282887142
• Report Number: 2134265-2021-16229
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729195566
• UDI-Public: 08714729195566
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/03/2022

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/25/2022
• Device Model Number: 3520
• Device Catalogue Number: 3520
• Device Lot Number: 0026423250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2021
• Initial Date FDA Received: 12/28/2021
• Supplement Dates Manufacturer Received: 01/19/2022
• Supplement Dates FDA Received: 02/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2020
• 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 Outcome(s): Death