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

Model Number	29720
Medical Device Problem Codes	Output Problem (3005); Noise, Audible (3273)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/27/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device went above the set operational speed.A 1.25mm peripheral rotalink plus was selected for use.Upon ablation, the device worked for the first two passes in the vessel and was then moved to another.The set operational speed was 160,000rpm, however the device went above the set operational speed as it reached at 165,000rpm at one point.An attempt for burr rotation was made but the physician would let go of the pedal as it sounded as if air was coming from the handle.A sound was heard, and the stall light lit up as soon as the physician stepped on the pedal.This was tried repeatedly using the same device but with no success.The procedure was completed with another of the same device.No patient complications were reported and everything is fine with the patient.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The advancer, handshake connections, sheath, coil, burr and annulus were visually and microscopically exanimated.Visual examination revealed no damages.Microscopic examination revealed that the coil is stretched.Functional testing was performed by attempting to rotate the drive shaft, however, it was unable to rotate due to a melted ultem.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that the device went above the set operational speed.A 1.25mm peripheral rotalink plus was selected for use.Upon ablation, the device worked for the first two passes in the vessel and was then moved to another.The set operational speed was 160,000rpm, however the device went above the set operational speed as it reached at 165,000rpm at one point.An attempt for burr rotation was made but the physician would let go of the pedal as it sounded as if air was coming from the handle.A sound was heard, and the stall light lit up as soon as the physician stepped on the pedal.This was tried repeatedly using the same device but with no success.The procedure was completed with another of the same device.No patient complications were reported and everything is fine with the patient.

• 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: 9847524
• Report Number: 2134265-2020-03504
• Device Sequence Number: 16749494
• Product Code: MCW
• UDI-Device Identifier: 08714729857808
• UDI-Public: 08714729857808
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 04/22/2020

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: 10/14/2021
• Device Model Number: 29720
• Device Catalogue Number: 29720
• Device Lot Number: 0024597911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2020
• Initial Date Received by Manufacturer: 02/27/2020
• Supplement Date Received by Manufacturer: 04/07/2020
• Initial Report FDA Received Date: 03/18/2020
• Supplement Report FDA Received Date: 04/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1