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

Model Number 3243

Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Intermittent Loss of Power (4016)

Patient Problems Chest Pain (1776); No Code Available (3191)

Event Date 06/01/2020

Event Type  Injury  

Manufacturer Narrative

Age at time of event: elderly.Date of event: the month and year of the event were provided.Used the first day in the month provided.

Event Description

It was reported that the burr stuck in the lesion, removal difficulties occurred and the patient experienced chest pain.The target lesion was located in the occluded graft to circumflex artery with the native circumflex having complex calcified stenosis involving the proximal circumflex, obtuse marginal branch, and ostium of the av groove branch.A 1.50mm rotapro and a rotawire were selected for use.The patient had previously undergone attempted intervention, utilizing balloon angioplasty with cutting balloon and conventional balloons; however, stenosis could not be successfully dilated due to the calcification.Initial guiding angioplasty showed a widely patent left main coronary artery and ostium.The anterior descending was totally occluded at its takeoff.The circumflex was diffusely diseased and gives rise to a large atrioventricular (av) groove branch.The av groove branch had an ostial stenosis, appearing to be somewhat calcified of approximately 70% diameter reduction.The remainder of the av groove branch was free of significant disease, distally giving rise to multiple posterior left ventricular branches.Just distal takeoff of the v groove branch, the circumflex had a long 70-80% stenosis, which is calcified.There was a more distal lesion of approximately 60%.More distally, the circumflex obtuse marginal had a 50% stenosis and then bifurcated into secondary branches.The more superior had retrograde flow into what appeared to be the distal stenosis of the bypass graft.The more distal obtuse marginal branch had a 50-60% stenosis and then continues giving rise to multiple secondary branches free of significant disease.Prior to the procedure, angiomax bolus infusion was given.The 0.010 rotawire was introduced in the lumen of the left coronary artery, advanced into the circumflex, manipulated across the multiple lesions into the distal obtuse marginal branch of the circumflex.The burr was platformed external to the patient to 160,000 rpms.The burr was then advanced under fluoroscopic guidance to the left main at 165,000 rpms.The burr was gently advanced into the proximal circumflex; however the burr jumped forward then immediately slowed down to 135,000 rpm and abruptly stopped rotating.The burr became fixed in place.The burr would no longer rotate, and the burr could not be advanced or pulled back.Nitroglycerin was administered with no effect.A two non-bsc guidewires along with a choice floppy wire were advanced to the left coronary artery but could not be successfully advanced to the burr.Angiography showed that the circumflex appeared to be totally occluded by the proximal end of the burr.A 6-french non-bsc guidecatheter was advanced to the circumflex, but the burr could not be removed within the guidecatheter.The guiding catheter was deep throated up to the burr and the physician pulled back directly on the exposed rotawire and was able to pull the burr in the guiding catheter, freeing it from the proximal obtuse marginal.The burr and the rotawire were removed intact from the patient.The left coronary was reengaged.Repeat angiography showed that the anterior descending, obtuse marginal and av groove branches remained patent, still with stenotic disease, not significantly changed, but no real change in the overall anatomy of the circumflex obtuse marginal and av groove branches.The patient experienced chest pain.The patient was placed on levophed, in which totally resolved the episode of chest pain.There were no electrocardiogram (ekg) changes.The patient remained in sinus rhythm, was hemodynamically stable, and was transferred back to the acute care unit for further monitoring and observation.There were no further patient complications reported.

• Brand Name: ROTAPRO
• 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; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10502516
• MDR Text Key: 206000052
• Report Number: 2134265-2020-12251
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729893363
• UDI-Public: 08714729893363
• 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,health
• Type of Report: Initial
• Report Date: 09/08/2020

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: 01/30/2022
• Device Model Number: 3243
• Device Catalogue Number: 3243
• Device Lot Number: 0025136176
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/18/2020
• Initial Date FDA Received: 09/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention