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

Model Number	3241
Medical Device Problem Codes	Device Damaged by Another Device (2915); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/15/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a rotawire fracture occurred.A 2.00mm rotalink plus and a 330cm rotawire were selected for use.During preparation, when the rotational speed was being set, it was noted that the rotawire became separated.Then, another rotawire was used; however, the burr was unable to load into the wire.The procedure was not completed due to this event.No patient complications were reported and patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.The returned complaint device consisted of a rotablator rotalink plus device.The advancer and burr catheter were received together.The advancer, handshake connections, sheath, coil, burr and annulus were microscopically and visually examined.There are numerous sheath kinks.Functional testing was performed using a test.009 rotawire.The test rotawire was attempted to be inserted into the burr tip and it would not pass the damaged annulus.The test wire was then inserted into the proximal end of the rotablator device and it advanced all the way through the device stopping at the damaged annulus.The coil is stretched.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that a rotawire fracture occurred.A 2.00mm rotalink plus and a 330cm rotawire were selected for use.During preparation, when the rotational speed was being set, it was noted that the rotawire became separated.Then, another rotawire was used; however, the burr was unable to load into the wire.The procedure was not completed due to this event.No patient complications were reported and patient's status was stable.

• 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: 8306702
• Report Number: 2134265-2019-00728
• Device Sequence Number: 1619665
• 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): 03/21/2019

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: 08/19/2020
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0022674136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2019
• Initial Date Received by Manufacturer: 01/15/2019
• Supplement Date Received by Manufacturer: 02/26/2019
• Initial Report FDA Received Date: 02/05/2019
• Supplement Report FDA Received Date: 03/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1