MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK ROTALINK¿ PLUS; CATHETER, CORONARY, ATHERECTOMY

Model Number H749236310020

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

Patient Problems Chest Pain (1776); Death (1802); Dyspnea (1816); Low Blood Pressure/ Hypotension (1914)

Event Date 11/02/2016

Event Type  Death  

Manufacturer Narrative

Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

Same case as mdr id: 2134265-2016-10663, 2134265-2016-10641.It was reported that the patient died.The target lesion was located in the proximal to middle left anterior descending artery(lad).A guide wire was advanced and a non-bsc balloon catheter was selected to the dilate lesion.The balloon was dilated but unable to expand the lesion due to excessive calcium.No visible change in the angiogram or dissection was noted.A 330 cm rotawire was advanced at the distal lad and a 1.25 mm rotalink plus was advanced.The first ablation was performed at 160,000 rpm without issues; however, during the third ablation, the patient experienced shortness of breath and complained of chest pain.Angiography was performed which revealed that the patient had slow flow- timi 1 or 2 flow down the lad.The rotalink plus was removed via dynaglide mode.Vasodilators were administered and blood flow had improved.The rotawire was exchanged to a workhorse wire and dilated the lesion with a 2.5x15 mm non-bsc balloon.A non-bsc imaging catheter was advanced to visualize the lumen of the lad.A 2.50 x 38 synergy ii everolimus-eluting platinum chromium coronary stent system was successfully implanted.Angiography was performed which revealed no dissection or perforation.However, the patient's pain and shortness of breath immediately increased and the systolic blood pressure dropped below 100 mm hg.In the next few minutes, the patient went into asystole and lost ekg and blood pressure.Cardiopulmonary resuscitation was immediately performed; however, the patient was not able to be revived and died.

• Brand Name: ROTALINK¿ PLUS
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer (Section G): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6128647
• MDR Text Key: 60929407
• Report Number: 2134265-2016-10695
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729316411
• UDI-Public: (01)08714729316411(17)20180131(10)18982322
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/02/2016

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: 01/31/2018
• Device Model Number: H749236310020
• Device Catalogue Number: 23631-002
• Device Lot Number: 18982322
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2016
• Initial Date FDA Received: 11/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2016
• 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
• Patient Age: 84 YR