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

Model Number	3241
Medical Device Problem Codes	Difficult to Remove (1528); Intermittent Loss of Power (4016)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the burr was difficult to remove.The target lesion was located in the severely tortuous and severely calcified right coronary artery.A 1.75mm rotalink plus was selected for use.After the ablation was completed, the stall lamp was turned on during dynaglide mode and the device could not be removed.So, both rotawire and rotaburr were removed together and the procedure was completed using this device.No complications were reported and there was no patient injury.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of the rotablator rotalink plus atherectomy device.The burr catheter was received attached to the advancer unit.The advancer, handshake connections, sheath, coil, burr and annulus were visually and microscopically examined.Inspection of the device presented no damage or irregularities.Functional testing was performed by attempting to rotate the drive shaft and the drive shaft was able to be rotated.The rotalink advancer was connected to the rotablator control console system.The rotablator advancer was able to reach optimum speed with no stalling or speed issues and no abnormal noises or leaks.The device was then placed in dynaglide and it ran with no stalling or speed issues too.Product analysis did not confirm the reported event, as the device was able to run in ablation and dynaglide modes with no stalling or speed issues.
Event or Problem Description
It was reported that the burr was difficult to remove.The target lesion was located in the severely tortuous and severely calcified right coronary artery.A 1.75mm rotalink plus was selected for use.After the ablation was completed, the stall lamp was turned on during dynaglide mode and the device could not be removed.So, both rotawire and rotaburr were removed together and the procedure was completed using this device.No complications were reported and there was no patient injury.

• Brand Name: ROTALINK PLUS
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11172639
• Report Number: 2134265-2021-00318
• Device Sequence Number: 3563340
• Product Code: MCX
• UDI-Device Identifier: 08714729228370
• UDI-Public: 08714729228370
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P900056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2021

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: 05/19/2021
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0023978553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2021
• Initial Date Received by Manufacturer: 01/05/2021
• Supplement Date Received by Manufacturer: 02/19/2021
• Initial Report FDA Received Date: 01/14/2021
• Supplement Report FDA Received Date: 03/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER - 6F JR 4.0; GUIDE CATHETER - 6F JR 4.0