MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM; CATHETER, CORONARY, ATHERECTOMY

Model Number UNK509

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Thrombosis (2100); Perforation of Vessels (2135); Pericardial Effusion (3271)

Event Date 11/21/2015

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

Same case as mdr# 2134265-2015-09100.It was reported that vessel perforation occurred.Vascular access was obtained through the right femoral artery.The de novo, >85% stenosed d1 bifurcation and >75% stenosed d1 ostium, were located in a severely tortuous and moderately calcified proximal to mid left anterior descending artery (lad).A 1.25mm rotalink plus was inserted inside the patient's body after a rotawire floppy crossed the lesion.During procedure, rotablation was done at 160,000 rpms; however, vessel perforation of the lad was noted on angiography.The perforation was then covered with a 2.8x16mm non bsc stent graft.Subsequently, patient suffered hypotension.An 8fr with 40cc intraaortic balloon pump (iabp) was passed through the right femoral artery and maintained the balloon at 1:1 augmentation.Two dimensional echocardiogram was done which then observed pericardial effusion.Pericardial centesis was then done and aspirated 100ml if blood.The mid lad was then stented with a 2.5x16mm non bsc drug eluting stent (des) deployed at 14atm fro 25secs, overlapping the stent graft.Subsequently, angiography was again done which revealed a thrombus in the stent graft.A balloon was passed and the stent graft was dilated with a 2.5x12mm nc balloon catheter at 6atm for 15 seconds.Heparin 2500 was then injected and angiography observed a small leak in the thrombolysis in myocardial infarction (timi) 2 flow.The physician then decided to send the patient for emergency coronary artery bypass grafting (cabg) due to the persistent leak through the perforation.The patient was then shifted to cardiac transplantation (ctot).There were no further patient complications reported and the patient's condition was stable.

• Brand Name: ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5324860
• MDR Text Key: 34289802
• Report Number: 2134265-2015-09390
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/27/2015

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 Model Number: UNK509
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/27/2015
• Initial Date FDA Received: 12/23/2015
• 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: GUIDE CATHETER: 7FR EBU
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR