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

Model Number	3320
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was cancelled.The target lesion was located in the left anterior descending artery.A 1.50mm rotalink burr, rotalink advancer w/ tubular drive shaft and console were selected for use.During preparation, it was noted that the console connector broke.The procedure was cancelled without complications reported, and patient was stable.
Event or Problem Description
It was reported that the procedure was cancelled.The target lesion was located in the left anterior descending artery.A 1.50mm rotalink burr, rotalink advacer w/ tubular drive shaft and console were selected for use.During preparation, it was noted that the console connector broke.The procedure was cancelled without complications reported, and patient was stable.It was further reported that the connection metal between the pedal and the console was fractured.The patient was sedated with a local anesthesia when the procedure was cancelled.
Event or Problem Description
It was reported that the procedure was cancelled.The target lesion was located in the left anterior descending artery.A 1.50mm rotalink burr, rotalink advacer w/ tubular drive shaft and console were selected for use.During preparation, it was noted that the console connector broke.The procedure was cancelled without complications reported, and patient was stable.It was further reported that the connection metal between the pedal and the console was fractured.The patient was sedated with a local anesthesia when the procedure was cancelled.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Visual inspection of the device did not identify any damages or defects.A photo was attached to the complaint showing the console dynaglide connector was damaged.The advancer used in the procedure was not returned for analysis.To determine burr catheter functionality, testing was performed with a test advancer.The testing consisted of connecting the rotalink burr catheter for this complaint to a test advancer.The advancer was connected to the console control system.The test advancer was able to reach and maintain optimal speed with no resistance or issues using the returned burr catheter.Product analysis did not confirm device performance issues, as there was no damage to the device, and it was able to function with a test advancer.

• 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: 19837675
• Report Number: 2124215-2024-46033
• Device Sequence Number: 7878078
• Product Code: MCX
• UDI-Device Identifier: 08714729185857
• UDI-Public: 08714729185857
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/28/2024

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: 08/20/2025
• Device Model Number: 3320
• Device Catalogue Number: 3320
• Device Lot Number: 0032259353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2024
• Supplement Date Received by Manufacturer: 07/28/2024; 10/11/2024
• Initial Report FDA Received Date: 07/26/2024
• Supplement Report FDA Received Date: 08/23/2024; 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2023
• 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
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 78 KG