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

Model Number	3320
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	12/03/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that burr became stuck and perforation occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified proximal to middle right coronary artery.A 1.75mm rotalink burr was selected for use.During the procedure, it was noted that the burr became stuck on third run deceleration.Dynaglide mode was used and tried to pull the burr, however, it was unable to get an additional non bsc wire proximal to stuck burr with intent to the balloon.Normal mode was used and the burr was able to retrieved.Subsequently, a perforation occurred in the proximal right coronary artery.Microcatheter was used to deliver wire, balloon and stents which were successfully deployed.The device was removed from the patient intact and the procedure was completed with a different device.No further patient complications were reported and patient was stable post procedure.
Event or Problem Description
It was reported that burr became stuck and perforation occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified proximal to middle right coronary artery.A 1.75mm rotalink burr was selected for use.During the procedure, it was noted that the burr became stuck on third run deceleration.Dynaglide mode was used and tried to pull the burr, however, it was unable to get an additional non bsc wire proximal to stuck burr with intent to the balloon.Normal mode was used and the burr was able to retrieved.Subsequently, a perforation occurred in the proximal right coronary artery.Microcatheter was used to deliver wire, balloon and stents which were successfully deployed.The device was removed from the patient intact and the procedure was completed with a different device.No further patient complications were reported and patient was stable post procedure.It was further reported that the burr was advanced through the lesion and into a slight angle where it became stuck in the proximal rca just distal to the lesion.

• Brand Name: ROTALINK BURR
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road cork; cork IRELA ND; EI IRELAND
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12953696
• Report Number: 2134265-2021-15434
• Device Sequence Number: 4316662
• Product Code: MCX
• UDI-Device Identifier: 08714729185840
• UDI-Public: 08714729185840
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P900056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2022

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: 11/07/2022
• Device Model Number: 3320
• Device Catalogue Number: 3320
• Device Lot Number: 0026477292
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/03/2021
• Supplement Date Received by Manufacturer: 12/22/2021
• Initial Report FDA Received Date: 12/07/2021
• Supplement Report FDA Received Date: 01/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown