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

Model Number 3241

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/18/2018

Event Type  Injury  

Event Description

It was reported that the drive shaft was broken and removed using balloon and guidezilla.The 80% stenosed target lesion was located in the severely tortuous and severely calcified right coronary artery.A 1.50mm rotalink plus was selected for use.During ablation, the drive shaft was found broken inside the patient's body and was then safely removed using balloon and guidezilla.Subsequently, it was noted that the brake defeat button was pressed while the rota burr was rotating.The procedure was completed with another of the same device.No complications were reported and patient is stable.

Event Description

It was reported that the drive shaft was broken and removed using balloon and guidezilla.The 80% stenosed target lesion was located in the severely tortuous and severely calcified right coronary artery.A 1.50mm rotalink plus was selected for use.During ablation, the drive shaft was found broken inside the patient's body and was then safely removed using balloon and guidezilla.Subsequently, it was noted that the brake defeat button was pressed while the rota burr was rotating.The procedure was completed with another of the same device.No complications were reported and patient is stable.It was further reported that there is no more residue inside the body and was safely removed from the patient.The technician also did not release the wire break button and was not locked during rotation.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.Returned product consisted of a rotablator rotalink plus device.The advancer unit and burr unit were received together.The burr and distal coil were not returned for analysis.The advancer, handshake connections, sheath, coil and burr were microscopically and visually examined.There are numerous sheath kinks.The coil is broken 145.5cm from the handshake connection.The coil is stretched.Inspection of the remainder of the device presented no other damage or irregularities.

• Brand Name: ROTALINK PLUS
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8199094
• MDR Text Key: 131487202
• Report Number: 2134265-2018-64615
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729228363
• UDI-Public: 08714729228363
• Combination Product (y/n): N
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/11/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 07/13/2020
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0022505279
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2019
• Initial Date Manufacturer Received: 12/19/2018
• Initial Date FDA Received: 12/27/2018
• Supplement Dates Manufacturer Received: 01/22/2019
• Supplement Dates FDA Received: 02/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR