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

Model Number 29720

Device Problems Output Problem (3005); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/27/2020

Event Type  malfunction  

Event 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.

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 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
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9847524
• MDR Text Key: 183889525
• Report Number: 2134265-2020-03504
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 08714729857808
• UDI-Public: 08714729857808
• Combination Product (y/n): N
• PMA/PMN Number: K121774
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 04/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1