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

Model Number	3241
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the burr became stuck on the guidewire.A percutaneous coronary intervention was being performed on a severely calcified lesion.A rotoblator rotalink plus 2.00mm and rotawire were being used for treatment.During the procedure, the physician had noticed the rotaburr and rotawire were stuck together.The physician could not release the devices, so they were removed together and replaced with similar devices.The new devices were used to complete the procedure successfully.No patient complications occurred due to this event.
Event or Problem Description
It was reported the burr became stuck on the guidewire.A percutaneous coronary intervention was being performed on a severely calcified lesion.A rotoblator rotalink plus 2.00mm and rotawire were being used for treatment.During the procedure, the physician had noticed the rotaburr and rotawire were stuck together.The physician could not release the devices, so they were removed together and replaced with similar devices.The new devices were used to complete the procedure successfully.No patient complications occurred due to this event.
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 rotawire used in the procedure was returned within the rotablator device.The advancer, handshake connections, sheath, coil, burr and annulus were visually examined.Inspection of the device presented no damage or irregularities.Functional testing was initially performed using the returned rotawire.During testing, the returned rotawire was able to be removed with resistance but was not able to be reinserted due to a kink at 38.5cm from the proximal end of the wire.In order to determine the functionality of the rotablator device, additional testing was performed using a test rotawire.The test rotawire was able to be fully inserted and removed from the rotablator device with no resistance or issues.Product analysis confirmed the reported event, as the returned rotawire was able to be removed with resistance but was not able to be reinserted due to a kink in the wire.

• Brand Name: ROTALINK PLUS
• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13937636
• Report Number: 2134265-2022-03578
• Device Sequence Number: 20441034
• Product Code: MCX
• UDI-Device Identifier: 08714729316442
• UDI-Public: 08714729316442
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 06/07/2022

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: 03/15/2023
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0027142610
• 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: 03/10/2022
• Supplement Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 03/29/2022
• Supplement Report FDA Received Date: 06/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2021
• 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 Sex: Unknown