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

Model Number	3241
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/04/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the burr detached.The target lesion was located in a severely tortuous and severely calcified left circumflex artery.A 2.0mm rotalink plus was selected for use.After ablation, resistance was felt when the burr was pulled upon removal and got detached at the boundary between the rotating burr and driveshaft.The detached burr was then removed by inserting a guidezilla and a new wire.The procedure was completed with this device.No complications reported and the patient was good.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for evaluation.Device analysis observed that the burr was detached from the coil.The coil was stretched prior to the burr separation indicating that force was applied during withdrawal of the device.
Event or Problem Description
It was reported that the burr detached.The target lesion was located in a severely tortuous and severely calcified left circumflex artery.A 2.0mm rotalink plus was selected for use.After ablation, resistance was felt when the burr was pulled upon removal and got detached at the boundary between the rotating burr and driveshaft.The detached burr was then removed by inserting a guidezilla and a new wire.The procedure was completed with this device.No complications reported and the patient was good.

• 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: 8831344
• Report Number: 2134265-2019-08769
• Device Sequence Number: 2079038
• Product Code: MCX
• UDI-Device Identifier: 08714729316442
• UDI-Public: 08714729316442
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P900056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2019

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: 09/14/2020
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0022791955
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2019
• Initial Date Received by Manufacturer: 07/05/2019
• Supplement Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 07/26/2019
• Supplement Report FDA Received Date: 08/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1