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

Model Number	3320
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the burr became stuck in the lesion and was snared to remove.The 28mmx4.0mm moderately stenosed target lesion was located in the moderately tortuous and slightly calcified proximal and middle right coronary artery.A 1.75mm rotalink burr was selected for use.During the procedure, after the burr was advanced to the lesion, in the process of high speed grinding, the burr became stuck and could not be withdrawn.The physician cut it off and grabbed it back with a snare.The device was completely removed from the patient's body and the procedure was completed with a different device.No complications were reported and the patient was stable post procedure.
Additional Manufacturer Narrative
Device evaluated by mfr: the rotalink burr catheter was received for product analysis.The burr catheter was received in two portions.The handshake connection, sheath, burr, and coil were microscopically and visually examined.Inspection of the device found that the sheath and coil had been cut 3.5cm from the distal end of the burr catheter strain relief.There was additional damage to the body of the sheath evident of interaction between the sheath and the coil due to stretching or pulling.Functional testing was not able to be performed due to the separation and clinical circumstances could not be replicated.
Event or Problem Description
It was reported that the burr became stuck in the lesion and was snared to remove.The 28mmx4.0mm moderately stenosed target lesion was located in the moderately tortuous and slightly calcified proximal and middle right coronary artery.A 1.75mm rotalink burr was selected for use.During the procedure, after the burr was advanced to the lesion, in the process of high speed grinding, the burr became stuck and could not be withdrawn.The physician cut it off and grabbed it back with a snare.The device was completely removed from the patient's body and the procedure was completed with a different device.No complications were reported and the patient was stable post procedure.

• 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: 12419014
• Report Number: 2134265-2021-10680
• Device Sequence Number: 3382955
• Product Code: MCX
• UDI-Device Identifier: 08714729185840
• UDI-Public: 08714729185840
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2021

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: 06/14/2021
• Device Model Number: 3320
• Device Catalogue Number: 3320
• Device Lot Number: 0024108660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2021
• Initial Date Received by Manufacturer: 08/12/2021
• Supplement Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 09/02/2021
• Supplement Report FDA Received Date: 09/30/2021
• 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
• Patient Age: 77 YR
• Patient Weight: 79