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

Model Number	H802227680050
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/19/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at the time of event: approximately (b)(6) old.Device evaluated by mfr: the device was not received for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical/procedural factors.(b)(4).
Event or Problem Description
Same case as 2134265-2016-12669.It was reported that the burr became stuck in lesion.The 80% stenosed target lesion was located in the tortuous and severely calcified left anterior descending artery.During the use of a 2.00mm rotalink¿ burr, the burr got stuck in the lesion.The burr was then tugged and removed for the patient's body.A 2.75 x 12 synergy ii everolimus-eluting platinum chromium coronary stent system was then deployed with excellent result.No patient complications were reported.Later that evening the patient experienced chest pain and had developed thrombosis.No further patient complications were reported and the patient¿s status was fine and stable.

• Brand Name: ROTALINK¿ BURR
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• MDR Report Key: 6256597
• Report Number: 2134265-2016-12464
• Device Sequence Number: 426925
• Product Code: MCX
• UDI-Device Identifier: 08714729126881
• UDI-Public: (01)08714729126881(17)20170228(10)0017789599
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P900056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2017
• Device Model Number: H802227680050
• Device Catalogue Number: 22768-005
• Device Lot Number: 0017789599
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2016
• Initial Report FDA Received Date: 01/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1