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

Model Number	3241
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/05/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that rotalink got separated.A 2.00mm rotalink plus was selected for use.During the procedure, the wire could not be inserted in to the burr and was noted that the rotalink got separated outside of the patient's body.The procedure was completed with another of the same device.No complications reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The returned complaint device consisted of a rotablator plus device.The burr catheter was attached to the advancer when received.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 by inserting a rota wire into the burr catheter and it was able to pass through.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found no separation or difficulty to insert a wire through the burr.
Event or Problem Description
It was reported that rotalink got separated.A 2.00mm rotalink plus was selected for use.During the procedure, the wire could not be inserted in to the burr and was noted that the rotalink got separated outside of the patient's body.The procedure was completed with another of the same device.No complications 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: 9835345
• Report Number: 2134265-2020-03224
• Device Sequence Number: 16468676
• 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): 04/03/2020

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: 01/04/2021
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0023292318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2020
• Initial Date Received by Manufacturer: 03/05/2020
• Supplement Date Received by Manufacturer: 04/02/2020
• Initial Report FDA Received Date: 03/16/2020
• Supplement Report FDA Received Date: 04/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1