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

Model Number 3241

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 12/24/2018

Event Type  Injury  

Event Description

It was reported that the burr became stuck, radial fracture noted upon burr removal and patient was intubated.The target lesion was located in the very calcified right coronary artery.A 1.75 mm rotalink plus was selected for use.During the procedure, it was noted that the burr was stuck after ablation and the shaft of the device ruptured and remained on the rotablator guide.The device was released and removed, consequently, radial fracture was further noted and was then treated by compression.The left femoral passage had major tortuosity with impossibility of catheterization of the ostium and the procedure was stop following a cv stop; requiring intubation for ventilation.The patient was then extubated at the end of the procedure.No further patient complications reported.

Event Description

It was reported that the burr became stuck, radial fracture noted upon burr removal and patient was intubated.The target lesion was located in the very calcified right coronary artery.A 1.75 mm rotalink plus was selected for use.During the procedure, it was noted that the burr was stuck after ablation and the shaft of the device ruptured and remained on the rotablator guide.The device was released and removed, consequently, radial fracture was further noted and was then treated by compression.The left femoral passage had major tortuosity with impossibility of catheterization of the ostium and the procedure was stop following a cv stop; requiring intubation for ventilation.The patient was then extubated at the end of the procedure.No further patient complications reported.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The returned complaint device consisted of a rotablator plus device.The advancer knob was not returned.The returned rotawire was received separately with the burr on it.The advancer, handshake connections, sheath, coil and burr were microscopically and visually examined.The coil is stretched and broken 142.7cm from the strain relief.Microscopic examination of the burr revealed that the annulus was damaged/fish-mouthed.The proximal end of the burr shows that the coil is broken.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

It was reported that the burr became stuck, radial fracture noted upon burr removal and patient was intubated.The target lesion was located in the very calcified right coronary artery.A 1.75 mm rotalink plus was selected for use.During the procedure, it was noted that the burr was stuck after ablation and the shaft of the device ruptured and remained on the rotablator guide.The device was released and removed, consequently, radial fracture was further noted and was then treated by compression.The left femoral passage had major tortuosity with impossibility of catheterization of the ostium and the procedure was stop following a cv stop; requiring intubation for ventilation.The patient was then extubated at the end of the procedure.No further patient complications reported.It was further reported that the burr was stuck in the proximal lesion of right coronary artery.The burr was released from being stuck by pulling the device hard.Subsequently, the device was broken in two pieces and the remainder of the device was removed by using a balloon and then capturing the device in the guide catheter.The device was removed with the guide catheter from the patient and no fragments were left inside the patient.The physician also stated that this was high risk procedure, with a very fragile patient.It was later reported that the patient died 5 days following the procedure unrelated to the device or the reported event.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The returned complaint device consisted of a rotablator plus device.The advancer knob was not returned.The returned rotawire was received separately with the burr on it.The advancer, handshake connections, sheath, coil and burr were microscopically and visually examined.The coil is stretched and broken 142.7cm from the strain relief.Microscopic examination of the burr revealed that the annulus was damaged/fish-mouthed.The proximal end of the burr shows that the coil is broken.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: 8311976
• MDR Text Key: 135210677
• Report Number: 2134265-2019-00791
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729228370
• UDI-Public: 08714729228370
• 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,Followup
• Report Date: 05/09/2019

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: 06/08/2020
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0022346885
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2019
• Initial Date Manufacturer Received: 01/14/2019
• Initial Date FDA Received: 02/06/2019
• Supplement Dates Manufacturer Received: 02/21/2019; 05/02/2019
• Supplement Dates FDA Received: 03/18/2019; 05/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention