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

Model Number 3241

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 10/25/2018

Event Type  Injury  

Event Description

It was reported that patient condition was not good.The 90% stenosed target lesion was located in severely calcified mid to distal left circumflex artery.A 1.25mm rotalink plus and a rotawire were selected for use.During the procedure, 1.5/15 non-bsc balloon was entered through a non-bsc wire but failed due to calcification severity and tortuosity.A rotawire was placed and the rotalink was advanced over the rotawire; however, it was noted that the patient was not good before the start of the ablation procedure.The procedure was completed a different device.No further patient complications were reported.

Manufacturer Narrative

This supplemental correction report is being filed to correct the report number in a previously submitted supplemental report (follow-up number 001) which was accepted by fda on 12/14/2018 10:47 am ct.The report number is being corrected from: 2134265-2018-64236 to: 2134265-2018-62405.

Event Description

It was reported that patient condition was not good the 90% stenosed target lesion was located in severely calcified mid to distal left circumflex artery.A 1.25mm rotalink plus and a rotawire were selected for use.During the procedure, 1.5/15 non-bsc balloon was entered through a non-bsc wire but failed due to calcification severity and tortuosity.A rotawire was placed and the rotalink was advanced over the rotawire, however, it was noted that the patient was not good before the start of the ablation procedure.The procedure was completed a different device.No further patient complications were reported.Device evaluated by manufacturer: the device was returned for analysis.Returned product consisted of a rotablator rotalink plus device.The burr catheter was received attached to the advancer.The advancer, coil, sheath, handshake connections, burr, and annulus were microscopically and visually examined.The coil is stretched.A test.009 rotawire was inserted through the burr and advanced through the entire length of the device with no resistance.Functional testing was performed by connecting the advancer to the rotablator control console system.The rotablator system was able to reach optimum speed with no issues and the burr catheter spun/moved with no issues.Inspection of the remainder of the device presented no other damage or irregularities.

• Brand Name: ROTALINK PLUS
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8025667
• MDR Text Key: 125706049
• Report Number: 2134265-2018-62405
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729316411
• UDI-Public: 08714729316411
• Combination Product (y/n): N
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/26/2020
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0022041219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2018
• Initial Date Manufacturer Received: 10/25/2018
• Initial Date FDA Received: 10/31/2018
• Supplement Dates Manufacturer Received: 11/27/2018
• Supplement Dates FDA Received: 01/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR