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

Model Number	3241
Medical Device Problem Codes	Difficult to Remove (1528); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was difficulty removing the device.A 1.75mm rotalink plus was selected for selected for a percutaneous coronary intervention (pci) procedure.During the procedure, a pecking motion was used for advancement and the rotalink was advanced.The device was tried to retrieve in dynaglide mode but it was difficult to remove from the patient.The physician then removed the device by hard pulling the device.After it was removed, the physician noticed the burr was damaged.The procedure was completed with another rotalink plus device and there were no patient complications reported.
Event or Problem Description
It was reported that there was difficulty removing the device.A 1.75mm rotalink plus was selected for selected for a percutaneous coronary intervention (pci) procedure.During the procedure, a pecking motion was used for advancement and the rotalink was advanced.The device was tried to retrieve in dynaglide mode but it was difficult to remove from the patient.The physician then removed the device by hard pulling the device.After it was removed, the physician noticed the burr was damaged.The procedure was completed with another rotalink plus device and there were no patient complications reported.It was further reported that the patient was good post procedure.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the returned product consisted of the rotalink burr catheter.The visual and microscope inspection of the device revealed that the coil was kinked and stretched at the handshake connection.The advancer used in the procedure was not returned for analysis, functional testing was performed using a test advancer.Functional testing was performed by connecting the rotablator advancer to the rotablator control console.During functional testing, the device stalled and would not run due to the kinked stretched coil.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that there was difficulty removing the device.A 1.75mm rotalink plus was selected for selected for a percutaneous coronary intervention (pci) procedure.During the procedure, a pecking motion was used for advancement and the rotalink was advanced.The device was tried to retrieve in dynaglide mode but it was difficult to remove from the patient.The physician then removed the device by hard pulling the device.After it was removed, the physician noticed the burr was damaged.The procedure was completed with another rotalink plus device and there were no patient complications reported.It was further reported that the patient was good post procedure.

• Brand Name: ROTALINK PLUS
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11801009
• Report Number: 2134265-2021-06066
• Device Sequence Number: 11752751
• Product Code: MCX
• UDI-Device Identifier: 08714729228370
• UDI-Public: 08714729228370
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/19/2021

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: 12/05/2022
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0026575719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2021
• Initial Date Received by Manufacturer: 05/05/2021
• Supplement Date Received by Manufacturer: 05/10/2021; 06/29/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 05/26/2021; 07/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1