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

Model Number	3241
Medical Device Problem Codes	Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/09/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there were twisting and burnt on the outer sheath.A 2.00mm rotalink plus was selected for use.During the functional testing it was noted that the outer sheath was twisted and burnt.The procedure was completed with another of same device.No patient complications were reported.
Event or Problem Description
It was reported that there were twisting and burnt on the outer sheath.A 2.00mm rotalink plus was selected for use.During the functional testing it was noted that the outer sheath was twisted and burnt.The procedure was completed with another of same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The returned complaint device consisted of a rotablator rotalink plus device.The burr catheter was received attached to the advancer unit.There is blood and contrast/saline visible in the annulus and between the coils.The advancer, handshake connections, sheath and coil were microscopically examined.Although it was reported that the device was not used, the presence of blood and contrast media is indicative of handling beyond simply unpackaging the device, as was reported.The sheath is kinked/twisted 5.7cm and 7.5cm from the distal end of the sheath.The coil is stretched.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: 8956493
• Report Number: 2134265-2019-10510
• Device Sequence Number: 11300479
• 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): 10/03/2019

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: 02/05/2021
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0023457462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2019
• Initial Date Received by Manufacturer: 08/09/2019
• Supplement Date Received by Manufacturer: 09/15/2019
• Initial Report FDA Received Date: 09/03/2019
• Supplement Report FDA Received Date: 10/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1