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

Model Number	3320
Medical Device Problem Codes	Difficult to Remove (1528); Output Problem (3005)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/24/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the burr became stuck inside a placed stent.The target lesion was located in 95% stenosed, moderately tortuous, heavily calcified in-stent restenosis with a stent length which presumed to be 60mm+ with diffuse of the right coronary artery.During procedure, a 1.75mm rotaburr was advanced and rotablated through the disease.Then, ballooning with nc balloons was performed; however, waisting of the balloons was visible due to remaining calcium.It was noted the non-compliant balloons were inflated at high pressure, however the force of the balloon was not enough to expand the calcium causing a waisting affect seen on the balloon.A 2.00mm rotalink burr was then selected for use.On advancement of the 2.00mm rotaburr, the speed decelerated, stalled and burr was stuck within the cage of the existing stent.Multiple removal techniques were attempted; however the patient had to be transferred to a cardiothoracic center for surgical removal of the burr.Consequently, the burr was unable to be removed, and the shaft of the burr was cut proximal to the stent.A surgically implanted by-pass graft was inserted to distal right coronary artery.The physician noted that patient is stable and recovering.

• Brand Name: ROTALINK BURR
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11922572
• Report Number: 2134265-2021-07033
• Device Sequence Number: 922736
• Product Code: MCX
• UDI-Device Identifier: 08714729126881
• UDI-Public: 08714729126881
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/02/2021

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: 09/12/2022
• Device Model Number: 3320
• Device Catalogue Number: 3320
• Device Lot Number: 0026172458
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 06/02/2021
• 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