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

Model Number H802227680030

Device Problem Entrapment of Device (1212)

Patient Problems Atrial Fibrillation (1729); Death (1802); Perforation of Vessels (2135)

Event Date 12/07/2017

Event Type  Death  

Manufacturer Narrative

(b)(4).Device evaluated by manufacturer: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).

Event Description

Same case as mdr id# 2134265-2017-12866 & 2134265-2017-12854.It was reported the burr became stuck in the lesion, patient complications arose, and the patient expired.The stenosed target lesion was located in the left anterior descending artery (lad).A 1.50mm rotalink¿ burr, rotawire¿, and rotalink¿ advancer were selected for use.During the procedure, the burr became stuck in the lesion resulting in a stall.Atrial fibrillation occurred and the lad vessel ruptured.The physician attempted to remove the burr, however, the attempt failed.The patient subsequently expired.

Manufacturer Narrative

Updated: describe event or problem.(b)(4).

Event Description

It was further reported that the event did not take place.The three devices reported in mdr id# 2134265-2017-12853, 2134265-2017-12854 and 2134265-2017-12866 was not used in the reported procedure.

• 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: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7159867
• MDR Text Key: 96313880
• Report Number: 2134265-2017-12853
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729185857
• UDI-Public: 08714729185857
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/11/2017

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: 04/15/2019
• Device Model Number: H802227680030
• Device Catalogue Number: 22768-003
• Device Lot Number: 0020643266
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2017
• Initial Date FDA Received: 01/03/2018
• Supplement Dates Manufacturer Received: 12/22/2017
• Supplement Dates FDA Received: 01/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2017
• 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: 74 YR