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

Model Number	3320
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of the burr detached.A 2.15mm rotalink burr was selected for use.During preparation, it was noted that the tip of the burr detached when unpacked and could not be used in the procedure.The procedure was completed with a different device.There were no patient complications reported and the patient is stable.
Event or Problem Description
It was reported that the tip of the burr detached.A 2.15mm rotalink burr was selected for use.During preparation, it was noted that the tip of the burr detached when unpacked and could not be used in the procedure.The procedure was completed with a different device.There were no patient complications reported and the patient is stable.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The handshake connection, sheath, burr, and coil were microscopically and visually examined.Inspection of the device found that the burr catheter handshake connection could not be retrieved within the housing.In order to inspect the handshake connection, the burr housing was dismantled.It was found that the coil was kinked and stretched at the handshake connection, and that the sheath was kinked.The handshake connection was unable to be retrieved due to the damage to the coil and sheath.

• 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: 12583409
• Report Number: 2134265-2021-12507
• Device Sequence Number: 3694898
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2021

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: 10/15/2021
• Initial Date Received by Manufacturer: 09/15/2021
• Supplement Date Received by Manufacturer: 10/22/2021
• Initial Report FDA Received Date: 10/06/2021
• Supplement Report FDA Received Date: 10/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 48