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

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problems Chest Pain (1776); Non specific EKG/ECG Changes (1817)

Event Date 03/18/2018

Event Type  Injury  

Manufacturer Narrative

Agarwal, praveer, et.Al., "distal protection device in entrapped rota ablation burr - a basket of delight," ihj cardiovascular case reports (cvcr) volume 3, issue 3, september-december 2020, pages 93-96.

Event Description

It was reported via journal article that shaft break and chest pain with st elevation occurred.The patient presented with complaints of chest pain nyha ii since 15 days.The patient was diagnosed as unstable angina and posted for coronary angiography.The 70-80% stenosed target lesion was tortuous and heavily calcified mid right coronary artery (rca).The patient was planned for a rota atherectomy with stenting to mid rca.Vascular access was taken with 7 f arterial and venous transfemoral routes.A non-boston scientific guide catheter was advanced over the non-boston scientific guidewire and engaged.Check angiography of the vessel revealed tortuous proximal segment.In view of the tortuous vessel guiding catheter was changed.The rotawire crossed the lesion and was placed in the distal rca.A 1.5mm rota burr rotablation was done in a pecking manner at the calcific lesion.During the third run of the rota ablation the burr got stuck into the calcified lesion with no antegrade or retrograde movement.The patient developed chest pain with st elevation.The patient was administered with various intracoronary vasodilators like nitroglycerine and diltiazem.The guide was deep throated and an attempt was made to pull the burr out with a gentle tug, which subsequently led to the shaft breaking at the junction of the burr and shaft, leaving the burr stuck into the vessel.The patient maintained hemodynamic stability post the stuck burr in the vessel.A non-boston scientific coronary guide wire was crossed alongside the burr over which pre-dilatation of the lesion was done using balloons to maintain timi iii flow across the vessel.Attempt to pull the burr proximally was also tried using a balloon but it failed.Post dilatation with these balloons the burr got released from the stuck site and advanced further down into the distal vessel which led to resolution of the chest pain and st changes.Another non-boston scientific wire was also passed into the vessel for support.A 5f distal protection device was then passed across the lesion and the embolized burr and deployed distal to the burr.The entire system was then pulled leaving only the guiding catheter in place.The embolized burr was successfully retrieved into the guide catheter.The lesion was then predilated with two balloons and stented with drug eluting stent with the help on a guide extension catheter.Post dilatation was done using 3.5mm and 4.0mm non compliant balloons.Final shoot revealed good timi iii flow with no dissection and no thrombus.The patient was discharged in a stable condition.

Manufacturer Narrative

B3: date of event: corrected from (b)(6) 2021 to (b)(6) 2018.Agarwal, praveer, et.Al., "distal protection device in entrapped rota ablation burr - a basket of delight," ihj cardiovascular case reports (cvcr) volume 3, issue 3, september-december 2020, pages 93-96.

Event Description

It was reported via journal article that shaft break and chest pain with st elevation occurred.The patient presented with complaints of chest pain nyha ii since 15 days.The patient was diagnosed as unstable angina and posted for coronary angiography.The 70-80% stenosed target lesion was tortuous and heavily calcified mid right coronary artery (rca).The patient was planned for a rota atherectomy with stenting to mid rca.Vascular access was taken with 7 f arterial and venous transfemoral routes.A non-boston scientific guide catheter was advanced over the non-boston scientific guidewire and engaged.Check angiography of the vessel revealed tortuous proximal segment.In view of the tortuous vessel guiding catheter was changed.The rotawire crossed the lesion and was placed in the distal rca.A 1.5mm rota burr rotablation was done in a pecking manner at the calcific lesion.During the third run of the rota ablation the burr got stuck into the calcified lesion with no antegrade or retrograde movement.The patient developed chest pain with st elevation.The patient was administered with various intracoronary vasodilators like nitroglycerine and diltiazem.The guide was deep throated and an attempt was made to pull the burr out with a gentle tug, which subsequently led to the shaft breaking at the junction of the burr and shaft, leaving the burr stuck into the vessel.The patient maintained hemodynamic stability post the stuck burr in the vessel.A non-boston scientific coronary guide wire was crossed alongside the burr over which pre-dilatation of the lesion was done using balloons to maintain timi iii flow across the vessel.Attempt to pull the burr proximally was also tried using a balloon but it failed.Post dilatation with these balloons the burr got released from the stuck site and advanced further down into the distal vessel which led to resolution of the chest pain and st changes.Another non-boston scientific wire was also passed into the vessel for support.A 5f distal protection device was then passed across the lesion and the embolized burr and deployed distal to the burr.The entire system was then pulled leaving only the guiding catheter in place.The embolized burr was successfully retrieved into the guide catheter.The lesion was then predilated with two balloons and stented with drug eluting stent with the help on a guide extension catheter.Post dilatation was done using 3.5mm and 4.0mm non compliant balloons.Final shoot revealed good timi iii flow with no dissection and no thrombus.The patient was discharged in a stable condition.

• 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
• MDR Report Key: 12328855
• MDR Text Key: 266841747
• Report Number: 2134265-2021-10408
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/18/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/10/2021
• Initial Date FDA Received: 08/16/2021
• Supplement Dates Manufacturer Received: 08/18/2021
• Supplement Dates FDA Received: 08/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 0.014X190 ALL-STAR WIREWAS; 0.014X190 ALL-STAR WIREWAS; 1.5 X12, 2X12 AND 2.5 X12 BALLOONS; 1.5 X12, 2X12 AND 2.5 X12 BALLOONS; 2.5X12 BALLOON; 2.5X12 BALLOON; 3.5 AND 4.0 MM NONCOMPLIANTBALLOON.; 3.5 AND 4.0 MM NONCOMPLIANTBALLOON.; 3.5X33 DRUG ELUTING STENT; 3.5X33 DRUG ELUTING STENT; 3X12, 3.5X12 BALLOONS; 3X12, 3.5X12 BALLOONS; 5 F DISTAL PROTECTION DEVICE; 5 F DISTAL PROTECTION DEVICE; 7F JR GUIDE CATHETER; 7F JR GUIDE CATHETER; A 0.014X190 BMW CORONARY GUIDE WIRE; A 0.014X190 BMW CORONARY GUIDE WIRE; TEFLONGUIDE WIRE; TEFLONGUIDE WIRE
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR