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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the burr was stuck in the lesion.The 95% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 2.15mm rotalink burr was selected for use.During the procedure, 3mm past the first bend in the vessel, it was noted that the burr became stuck in the lesion.The device was directly removed from the patient's body with slight resistance.The procedure was completed with a different device.No patient complications were reported and the patient was stable post procedure.
Event or Problem Description
It was reported that the burr was stuck in the lesion.The 95% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 2.15mm rotalink burr was selected for use.During the procedure, 3mm past the first bend in the vessel, it was noted that the burr became stuck in the lesion.The device was directly removed from the patient's body with slight resistance.The procedure was completed with a different device.No patient complications were reported and the patient was stable post procedure.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the returned product consisted of the rotalink burr catheter.The handshake connection, sheath, burr, and coil were visually examined.Inspection of the device presented no damage or irregularities.The rotalink advancer that was used in the procedure was not returned for analysis.Functional testing was performed with a test advancer which was connected to the rotablator control console system and was able to reach optimum speed with no issues and there were no abnormal noises or leaks.There was no damage to the device, the burr was able to rotate and reach optimum speed during functional testing, and the clinical circumstances could not be replicated.

• 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: 12550970
• Report Number: 2134265-2021-11447
• Device Sequence Number: 11041048
• Product Code: MCX
• UDI-Device Identifier: 08714729185826
• UDI-Public: 08714729185826
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2021

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: 09/21/2021
• Device Model Number: 3320
• Device Catalogue Number: 3320
• Device Lot Number: 0024637677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2021
• Initial Date Received by Manufacturer: 09/06/2021
• Supplement Date Received by Manufacturer: 10/08/2021
• Initial Report FDA Received Date: 09/29/2021
• Supplement Report FDA Received Date: 10/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 84