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

Model Number	29720
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/24/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the burr detached.The target lesion was located in the right anterior tibial artery.A 2.00mm peripheral rotalink plus was selected for use in a right anterior tibial artery atherectomy.During procedure, it was noted that the burr broke off from the drive shaft inside the patient's body.The procedure was completed with another of the same device.No patient complications reported and patient was fine.
Event or Problem Description
It was reported that the burr detached.The target lesion was located in the right anterior tibial artery.A 2.00mm peripheral rotalink plus was selected for use in a right anterior tibial artery atherectomy.During procedure, it was noted that the burr broke off from the drive shaft inside the patient's body.The procedure was completed with another of the same device.No patient complications reported and patient was fine.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the returned product consisted of a peripheral rotablator plus device.The advancer unit and burr catheter were received together.The returned rotawire was received in the device.The rotawire was able to be removed from the device with no issue.The advancer, coil, sheath, handshake connections, burr, and annulus were microscopically examined.The burr is intact on the coil.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.Inspection of the remainder of the device presented no other damage or irregularities.

• 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: 9943085
• Report Number: 2134265-2020-04580
• Device Sequence Number: 18999125
• Product Code: MCW
• UDI-Device Identifier: 08714729838920
• UDI-Public: 08714729838920
• 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): 05/18/2020

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: 10/28/2021
• Device Model Number: 29720
• Device Catalogue Number: 29720
• Device Lot Number: 0024677428
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2020
• Initial Date Received by Manufacturer: 03/26/2020
• Supplement Date Received by Manufacturer: 05/13/2020
• Initial Report FDA Received Date: 04/09/2020
• Supplement Report FDA Received Date: 05/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR