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

Model Number	3280
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was cancelled.A rotalink advancer was selected for use.During preparation, when the physician was connecting the device to nitrogen, the advancer was found leaking.The procedure was cancelled due to this event and the patient was sedated.No complications were reported, and the patient status is stable.
Additional Manufacturer Narrative
Device evaluated by manufacturer: returned product consisted of the rotablator rotalink plus atherectomy device.The burr catheter was received attached to the advancer unit.The advancer, handshake connections, sheath, coil, burr and annulus were visually examined.Inspection of the device presented no damage or irregularities.Functional testing was performed by attempting to rotate the drive shaft, and the drive shaft was not able to be rotated.When the rotablator advancer was connected to the rotablator console control system and the foot pedal was pressed, the device stalled and would not run.The sound of air escaping the device was heard during the stall.In order to determine the cause for the device stall, destructive testing was performed, in which the advancer was dismantled and the interior components were examined.Destructive testing was not able to determine the cause of the stall.Product analysis confirmed the reported event, as the sound of air escaping the device could be heard during the device stall.Destructive testing was not able to confirm the cause of the stall.
Event or Problem Description
It was reported that the procedure was cancelled.A rotalink advancer was selected for use.During preparation, when the physician was connecting the device to nitrogen, the advancer was found leaking.The procedure was cancelled due to this event and the patient was sedated.No complications were reported, and the patient status is stable.

• Brand Name: ROTALINK ADVANCER
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15581039
• Report Number: 2124215-2022-40493
• Device Sequence Number: 12377250
• Product Code: MCX
• UDI-Device Identifier: 08714729317739
• UDI-Public: 08714729317739
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2022

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: 07/14/2023
• Device Model Number: 3280
• Device Catalogue Number: 3280
• Device Lot Number: 0027834261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/26/2022
• Supplement Date Received by Manufacturer: 11/21/2022
• Initial Report FDA Received Date: 10/11/2022
• Supplement Report FDA Received Date: 12/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2021
• 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: 60 YR
• Patient Sex: Male
• Patient Weight: 130 KG