MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTALINK PLUS; CATHETER, CORONARY, ATHERECTOMY

Model Number	3241
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/07/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the burr was stuck in the lesion.The target lesion was located in right coronary artery.A 2.00mm rotalink plus was selected for use.During the procedure, the device able to pass the target lesion.However, it became stuck in the lesion.The burr was released from being stuck through surgery.No further patient complications were reported and patient is stable.
Event or Problem Description
It was reported that the burr was stuck in the lesion.The target lesion was located in right coronary artery.A 2.00mm rotalink plus was selected for use.During the procedure, the device able to pass the target lesion.However, it became stuck in the lesion.The burr was released from being stuck through surgery.No further patient complications were reported and patient is stable.It was further reported via medwatch (b)(4) that the target lesion was 99% calcified.During the initial first pass of the burr thru the 8fr guiding system, improvement of the lumen was noted.The burr was then upsized and the rotablator was able to advanced past the lesion.However, the device was not able to dynaglide back into the guide.Consequently, the patient was sent to the operating room for coronary artery bypass graft (cabg).
Additional Manufacturer Narrative
Updated lot number from 23070796 to 0022877096.(b)(4).

• Brand Name: ROTALINK PLUS
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8374432
• Report Number: 2134265-2019-01786
• Device Sequence Number: 2228909
• Product Code: MCX
• UDI-Device Identifier: 08714729316442
• UDI-Public: 08714729316442
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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,Followup
• Report Date (Section B): 04/02/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/01/2020
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0022877096
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/07/2019
• Supplement Date Received by Manufacturer: 03/11/2019
• Initial Report FDA Received Date: 02/27/2019
• Supplement Report FDA Received Date: 04/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR