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

Model Number	3241
Medical Device Problem Codes	Entrapment of Device (1212); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/26/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the burr became stuck to the wire.A stenosed target lesion was located at severely calcified coronary artery.A 2.15mm rotalink plus and rotawire was selected for use.During the procedure, it was reported that the burr got stuck on the wire during removal attempts.The procedure was completed using the same device.There were no patient complications reported.
Event or Problem Description
It was reported that the burr became stuck to the wire.A stenosed target lesion was located at severely calcified coronary artery.A 2.15mm rotalink plus and rotawire was selected for use.During the procedure, it was reported that the burr got stuck on the wire during removal attempts.The procedure was completed using the same device.There were no patient complications reported.Device evaluated by mfr: the device was returned for evaluation.Returned product consisted of a rotablator rotalink plus device.The advancer unit and burr unit were received together.The advancer, coil, sheath, handshake connections, burr, and annulus were microscopically and visually examined.A test.009 rotawire was inserted through the burr and advanced through the entire length of the device with no resistance.Microscopic examination of the device revealed that the annulus was damaged and not rounded which is consistent with damage seen with the use of a rotawire.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis did not confirm the reported event.No other issues reported.

• 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: 7984895
• Report Number: 2134265-2018-62110
• Device Sequence Number: 1707256
• Product Code: MCX
• UDI-Device Identifier: 08714729316473
• UDI-Public: 08714729316473
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P900056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2018

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: 11/11/2019
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0021494762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2018
• Initial Date Received by Manufacturer: 10/12/2018
• Supplement Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 10/19/2018
• Supplement Report FDA Received Date: 12/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1