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

Model Number	3241
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/03/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was difficulty in removing the burr.A 2.00mm rotalink plus was selected for use along with a rotawire.During the procedure, it was noted that there was difficulty removing the burr due to resistance with the rotawire.The burr was removed from the patient independently off the wire.There was no additional intervention required.The procedure was completed with a different device.No complications reported.
Event or Problem Description
It was reported that there was difficulty in removing the burr.A 2.00mm rotalink plus was selected for use along with a rotawire.During the procedure, it was noted that there was difficulty removing the burr due to resistance with the rotawire.The burr was removed from the patient independently off the wire.There was no additional intervention required.The procedure was completed with a different device.No complications reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The advancer, handshake connection, sheath, coil, burr and annulus were microscopically and visually examined.Visual and microscopic examination revealed no damages.Device to device interaction test was performed and a test rota guidewire was able to pass through the device.Inspection of the remainder of the device presented no other damage or irregularities.

• 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: 9982633
• Report Number: 2134265-2020-05339
• Device Sequence Number: 11721608
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2020

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: 10/18/2021
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0024788534
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2020
• Initial Date Received by Manufacturer: 04/03/2020
• Supplement Date Received by Manufacturer: 06/23/2020
• Initial Report FDA Received Date: 04/21/2020
• Supplement Report FDA Received Date: 07/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ROTAWIRE AND WIRECLIP TORQUER.; ROTAWIRE AND WIRECLIP TORQUER.; ROTAWIRE AND WIRECLIP TORQUER