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

Model Number	29720
Medical Device Problem Codes	Entrapment of Device (1212); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Intraoperative Pain (2662); Vascular Dissection (3160)
Date of Event	10/18/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the burr became stuck in the lesion and also became stuck with the wire.Also, the patient experienced pain and vessel dissection.The heavily calcified target lesion was located in the right anterior tibial artery.A 1.50mm peripheral rotalink plus and a rotawire were selected for used.During the procedure, when the rotaburr was advanced, it was noted that the device became stuck in the vessel.The physician believed the burr wrapped on a dissection flap.The burr also became bound to the wire and therefore they were removed together.However, it was further noted that the patient experienced pain during the removal of the devices, and a vessel dissection occurred in the proximal anterior tibial artery.The dissection was not flow limiting.The case was aborted due to this event.No further patient complications were reported.
Event or Problem Description
It was reported that the burr became stuck in the lesion and also became stuck with the wire.Also, the patient experienced pain and vessel dissection.The heavily calcified target lesion was located in the right anterior tibial artery.A 1.50mm peripheral rotalink plus and a rotawire were selected for used.During the procedure, when the rotaburr was advanced, it was noted that the device became stuck in the vessel.The physician believed the burr wrapped on a dissection flap.The burr also became bound to the wire and therefore they were removed together.However, it was further noted that the patient experienced pain during the removal of the devices, and a vessel dissection occurred in the proximal anterior tibial artery.The dissection was not flow limiting.The case was aborted due to this event.No further patient complications were reported.Device evaluated by manufacturer: device was returned for analysis.Returned product consisted of a rotablator rotalink plus device.The advancer unit and burr unit were received separated.A microscopic and visual examination of the complaint unit was carried out and was reported that the handshake connection was bent.The sheath was cut 1.8cm from the strain relief.The distal portion of the sheath was not returned for analysis.There is blood in the sheath that was received.The burr catheter handshake connection is not visible and would not retract.The housing was removed revealing that the handshake connection was stuck down in the sheath.The coil is stretched and detached.The detached distal portion of the coil has part of the returned wire in it.The burr was soaked in hot water in an attempt to remove the wire; however the wire could not be removed from the burr catheter coil.The both portions of the wire and the separated distal coil that is stuck on the wire were sent to coyol cis.Functional testing was performed by connecting the advancer to the rotablator control console system.There were no abnormal noises or leaks and the device did not run; so it was not able to get any speed.The advancer was dismantled and the ultem was found to be melted and the turbine was corroded.Product analysis confirmed the reported event due to the melted ultem.

• 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: 8028818
• Report Number: 2134265-2018-62423
• Device Sequence Number: 1105261
• Product Code: MCW
• UDI-Device Identifier: 08714729838906
• UDI-Public: 08714729838906
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 12/04/2018

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: 08/20/2020
• Device Model Number: 29720
• Device Catalogue Number: 29720
• Device Lot Number: 0022541058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2018
• Initial Date Received by Manufacturer: 10/18/2018
• Supplement Date Received by Manufacturer: 11/16/2018
• Initial Report FDA Received Date: 11/01/2018
• Supplement Report FDA Received Date: 12/04/2018
• 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