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	11/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the wire got stuck within the burr.The target lesion was located in the mildly tortuous and mildly calcified mid left anterior artery.A 1.75mm rotalink plus was selected for use.During the procedure, it was noted that the wire got stuck in the burr.The procedure was completed with another of the same device.No patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the returned product consisted of the rotablator rotalink atherectomy device.The burr catheter was received attached to the advancer unit.The rotawire used in the procedure was also returned and was received within the rotablator device.The advancer, handshake connections, sheath, coil, burr and annulus were visually and microscopically examined.Inspection presented no damage or irregularities to the device.Functional testing was performed by attempting to remove the returned rotawire, and the returned rotawire was able to be removed without issues.The returned rotawire was then able to be reinserted and passed through the device with no resistance or issues.
Event or Problem Description
It was reported that the wire got stuck within the burr.The target lesion was located in the mildlt tortuous and mildly calcified left anterior artery.A 1.75mm rotalink plus was selected for use.During the procedure, it was noted that the wire got stuck in the burr.The procedure was completed with another of the same device.No patient complications reported.Device evaluated by manufacturer: the device was returned for analysis.The advancer, handshake connections, sheath, coil, burr and annulus were visually and microscopically examined.Inspection presented no damage or irregularities to the device.Functional testing was performed by attempting to remove the returned rotawire, and the returned rotawire was able to be removed without issues.The returned rotawire was then able to be reinserted and passed through the device with no resistance or issues.Product analysis was not able to confirm the reported events, as the returned rotawire was able to be removed from and reinserted into the rotablator device with no resistance or issues.

• 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; cork IRELA ND; EI IRELAND
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12865067
• Report Number: 2134265-2021-14786
• Device Sequence Number: 1441370
• Product Code: MCX
• UDI-Device Identifier: 08714729228370
• UDI-Public: 08714729228370
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 01/06/2022

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: 12/24/2021
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0025096568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2021
• Supplement Date Received by Manufacturer: 12/22/2021
• Initial Report FDA Received Date: 11/23/2021
• Supplement Report FDA Received Date: 01/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2020
• 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: 61 YR
• Patient Sex: Male