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 Consequences Or Impact To Patient (2199)
Date of Event	01/28/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the burr became stuck in the lesion.The 25mm, 75% stenosed target lesion was located in the moderately tortuous and severely calcified distal right coronary artery.A 2.00mm rotalink plus was selected for use.During the procedure, the operational speed of the burr was set at 190,000rpm.The rotational speed for each ablation was at 160,000 to 170,000rpm for 10 seconds.At the course of the procedure, it was noted that the burr became stuck and penetrated in the distal part of the target lesion as the area was tight.Furthermore, the burr was difficult to remove.Consequently, a non bsc 6f guide catheter was inserted with a non bsc guidewire and ballooning was performed with a 3.0x12mm non bsc balloon in the proximal part of the area where the burr was stuck and then the burr was eventually released.No further patient complications were reported and the patient's status 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: 8354187
• Report Number: 2134265-2019-01405
• Device Sequence Number: 2371281
• 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
• Report Date (Section B): 02/20/2019

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: 0022791947
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2019
• Initial Report FDA Received Date: 02/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR