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

Model Number	29720
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	12/12/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the burr broke off and the patient experienced a small perforation.The 60mm target lesion was located in the severely calcified right peroneal artery.A 1.75mm peripheral rotalink plus and rotawire were selected for use.During the procedure, after treating approximately 20mm of the heavily calcified peroneal artery, it was noted that the burr broke off.The physician was able to remove the rotawire with the burr still entrapped on the wire.Consequently, the patient had a small perforation in the occluded segment of the peroneal artery during withdrawal.The peroneal artery was no longer possible to cannulate.The procedure was unsuccessful.No other devices were used after because they were unable to get a wire back down across the diseased segment of the artery.No further patient complications were reported and the patient was fine.
Event or Problem Description
It was reported that the burr broke off and the patient experienced a small perforation.The 60mm target lesion was located in the severely calcified right peroneal artery.A 1.75mm peripheral rotalink plus and rotawire were selected for use.During the procedure, after treating approximately 20mm of the heavily calcified peroneal artery, it was noted that the burr broke off.The physician was able to remove the rotawire with the burr still entrapped on the wire.Consequently, the patient had a small perforation in the occluded segment of the peroneal artery during withdrawal.The peroneal artery was no longer possible to cannulate.The procedure was unsuccessful.No other devices were used after because they were unable to get a wire back down across the diseased segment of the artery.No further patient complications were reported and the patient was fine.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for evaluation.Returned product consisted of a rotablator rotalink plus device.The advancer unit and burr unit were received together.The burr was received separated on the returned rotawire.The advancer knob was received separated from the advancer.The advancer, handshake connections, sheath, coil and burr were microscopically and visually examined.There are numerous sheath kinks.The coil is broken 146.5cm from the handshake connection.The coil is stretched.The burr was removed from the rotawire.Microscopic examination of the burr revealed that the annulus was damaged and not rounded which is consistent with damage seen with the use of a rotawire.No other issues reported.

• Brand Name: PERIPHERAL ROTALINK PLUS
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8208533
• Report Number: 2134265-2018-64700
• Device Sequence Number: 16212326
• Product Code: MCW
• UDI-Device Identifier: 08714729838913
• UDI-Public: 08714729838913
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K121774
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/03/2020
• Device Model Number: 29720
• Device Catalogue Number: 29720
• Device Lot Number: 0022335572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2018
• Initial Date Received by Manufacturer: 12/12/2018
• Supplement Date Received by Manufacturer: 01/09/2019
• Initial Report FDA Received Date: 01/02/2019
• Supplement Report FDA Received Date: 01/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR