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

Model Number	3320
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a connection issue and break occurred, and the procedure was cancelled.A 1.75mm rotalink burr was selected for use.During the procedure, it was noted that the handshake connection of the burr was bent and possibly broken.It was not possible to connect the burr to the advancer.The procedure was not continued and there were no patient complications reported.
Event or Problem Description
It was reported that a connection issue and break occurred, and the procedure was cancelled.A 1.75mm rotalink burr was selected for use.During the procedure, it was noted that the handshake connection of the burr was bent and possibly broken.It was not possible to connect the burr to the advancer.The procedure was not continued and there were no patient complications reported.It was further reported and confirmed that procedure was completed using an alternate device.
Additional Manufacturer Narrative
Correction- impact code h6 updated to f26: no health consequences or impact.

• Brand Name: ROTALINK BURR
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18230362
• Report Number: 2124215-2023-63943
• Device Sequence Number: 12312645
• Product Code: MCX
• UDI-Device Identifier: 08714729185840
• UDI-Public: 08714729185840
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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): 12/21/2023

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: 06/16/2025
• Device Model Number: 3320
• Device Catalogue Number: 3320
• Device Lot Number: 0032031965
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2023
• Supplement Date Received by Manufacturer: 11/30/2023
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2023
• 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: Hospitalization
• Patient Sex: Unknown