MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK ROTALINK? BURR; CATHETER, CORONARY, ATHERECTOMY

Model Number H802227680020

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

Patient Problems Intimal Dissection (1333); Cardiopulmonary Arrest (1765); Death (1802); Thrombosis (2100)

Event Date 11/17/2014

Event Type  Death  

Event Description

Same case as mfr #: 2134265-2014-07856, 2134265-2014-07857, 2134265-2014-07859, 2134265-2014-07860, 2134265-2014-07861, 2134265-2014-07970.It was reported that a dissection, thrombosis and death occurred.The 90% stenosed lesion was located in the calcified and moderately tortuous coronary artery.A 7fr wiseguide catheter was positioned in the main coronary artery.A 1.25mm rotalink and a 330cm rotawire were selected to treat the lesion.While performing platform testing outside of the patient, the burr fractured the guide wire.The devices were exchanged for another 1.25 rotalink burr and another 330cm rotawire.The rotawire was positioned in the artery.While inserting the tip of the burr inside the wiseguide catheter, it was noted that the physician may not have had a proper hold on the catheter and ¿intubated¿ the artery resulting in a dissection.The catheter was removed and ¿clottings¿ were noted on site.Rotablation was not performed.The dissection was treated with two promus element plus stents, a 3.50x20mm and a 2.50x38mm, in the anterior descending and the circumflex arteries.However, thrombosis occluded the artery and the patient died in the icu approximately 10-15 minutes after the procedure.The physician indicated that the devices performed as expected and that the dissection occurred due to the condition of the patient.

Event Description

It was further reported the patient went into cardio respiratory arrest and did not respond to resusciation efforts.

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).

Manufacturer Narrative

(b)(4).

• Brand Name: ROTALINK? BURR
• 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4338415
• MDR Text Key: 5198963
• Report Number: 2134265-2014-07858
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/21/2014

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: 10/31/2015
• Device Model Number: H802227680020
• Device Catalogue Number: 22768-002
• Device Lot Number: 0016543625
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2014
• Initial Date FDA Received: 12/17/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2013
• 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; Required Intervention