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

Model Number 3241

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/09/2020

Event Type  Injury  

Event Description

It was reported that the burr became stuck in the lesion.The 99% stenosed, 20mm in length target lesion was located in the severely calcified and moderately tortuous right coronary artery (rca) segment 2.A 1.25mm rotablator rotalink plus was selected for an atherectomy procedure.The device was prepared outside the body and platformed at 160,000rpm.During the procedure, the burr was advanced in dynaglide mode through the guide catheter and a pecking motion was used during advancement.The first 15mm were able to be ablated smoothly with no resistance.Ablation was performed at speeds between 160000 and 165000rpm.Then while moving the advancer knob back and forth with no resistance, it was observed that the burr itself was not moving simultaneously.Suddenly, the burr become stuck in the rca and the drive shaft broke.The drive shaft sheath was cut and a non-bsc guide extension catheter was used to remove the device out of the patient's body.The procedure was stopped and the last 2 mm remained calcified.There were no patient complications reported and the patient's status was stable post procedure.

Manufacturer Narrative

Device evaluated by manufacturer: the rotablator rotalink plus device was returned in three pieces; the damaged burr catheter and housing were attached to the advancer unit.The advancer, handshake connections, sheath, coil, burr, and annulus were examined both visually and microscopically.The sheath was separated 1 mm from the strain relief, consistent with the report that the drive shaft sheath was cut prior to removal.The sheath was also severely kinked in numerous locations.The coil was stretched and broken (138.2 cm from the distal end of the burr); however, the burr was still intact on the coil.Microscopic examination revealed that the annulus was not rounded, which is consistent with damage incurred with use of a rotawire.Functional testing was then performed without the burr catheter unit, as it was severely damaged and would not be able to run with the advancer.The burr catheter handshake connection was removed from the advancer, and the rotablator advancer unit was connected to the rotablator control console system; the rotablator advancer unit was able to reach optimum speed with no issues.

Event Description

It was reported that the burr became stuck in the lesion.The 99% stenosed, 20mm in length target lesion was located in the severely calcified and moderately tortuous right coronary artery (rca) segment 2.A 1.25mm rotablator rotalink plus was selected for an atherectomy procedure.The device was prepared outside the body and platformed at 160,000rpm.During the procedure, the burr was advanced in dynaglide mode through the guide catheter and a pecking motion was used during advancement.The first 15mm were able to be ablated smoothly with no resistance.Ablation was performed at speeds between 160000 and 165000rpm.Then while moving the advancer knob back and forth with no resistance, it was observed that the burr itself was not moving simultaneously.Suddenly, the burr become stuck in the rca and the drive shaft broke.The drive shaft sheath was cut and a non-bsc guide extension catheter was used to remove the device out of the patient's body.The procedure was stopped and the last 2 mm remained calcified.There were no patient complications reported and the patient's status was stable post procedure.

• 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: 10302707
• MDR Text Key: 199702180
• Report Number: 2134265-2020-09568
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729316411
• UDI-Public: 08714729316411
• 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: 10/01/2020

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: 09/07/2020
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0022762473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2020
• Initial Date Manufacturer Received: 07/09/2020
• Initial Date FDA Received: 07/21/2020
• Supplement Dates Manufacturer Received: 09/15/2020
• Supplement Dates FDA Received: 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention