MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM; CATHETER, CORONARY, ATHERECTOMY

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

Patient Problem Cardiac Perforation (2513)

Event Date 05/01/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: used the first date of the month of the aware date as no event date was provided.

Event Description

Reported via journal article.It was reported that perforation of the artery occurred.A rotawire and a rotablator burr were selected for use.During a rotablation procedure of the left main coronary artery (lmca) and left circumflex artery (lcx), perforation of the ostial left circumflex artery (lcx) occurred.Multiple attempts of balloon tamponade were done along with a non bsc covered stent deployed from the proximal lcx into the lmca.Subsequently, an acute exclusion of the left anterior descending (lad) artery from the coronary circulation was observed.A dual lumen catheter and stiff wire was advanced through the side port towards the occluded lad to fenestrate the membrane of the covered stent.In addition, a series of balloons used to dilate the fenestration in the covered stent to restore a normal flow.No further patient complications reported.Treatment of rotablation-induced ostial left circumflex perforation by papyrus covered stent and its fenestration to recover the left anterior descending artery during chip procedure.Catheterization and cardiovascular interventions 2019: 93 (6) p.E331-e336.

• Brand Name: ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC LTD; business & technology park; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 8709004
• MDR Text Key: 148333322
• Report Number: 2134265-2019-07038
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 06/18/2019

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/24/2019
• Initial Date FDA Received: 06/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: ROTAWIRE AND WIRECLIP TORQUER
• Patient Outcome(s): Other