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

Model Number	3241
Medical Device Problem Codes	Device Contamination with Chemical or Other Material (2944); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that shavings came out from the burr.A 2.00mm rotalink plus was selected for use.During preparation, resistance was encountered when inserting the rotawire into the rotaburr.Subsequently, objects like shavings came out from the tip of the burr.The procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
Initial reporter city: (b)(6).Device evaluated by the manufacturer: the device was returned for analysis: the advancer, handshake connections, sheath, coil, burr and annulus were visually and microscopically examined.There are numerous sheath kinks.The burr was received with dried saline in the annulus, so the burr was soaked in hot water for a short time to remove the saline.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.The coil is stretched.Functional testing was performed using a test.009 rotawire.The test rotawire was inserted through the burr and advanced through the entire length of the rotablator plus device with no resistance.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that shavings came out from the burr.A 2.00mm rotalink plus was selected for use.During preparation, resistance was encountered when inserting the rotawire into the rotaburr.Subsequently, objects like shavings came out from the tip of the burr.The procedure was completed with another of the same device.There were no patient 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: 8795969
• Report Number: 2134265-2019-08193
• Device Sequence Number: 16638602
• 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): 09/26/2019

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: 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: 08/16/2019
• Initial Date Received by Manufacturer: 06/20/2019
• Supplement Date Received by Manufacturer: 09/05/2019
• Initial Report FDA Received Date: 07/16/2019
• Supplement Report FDA Received Date: 09/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1