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

Model Number 29720

Device Problems Entrapment of Device (1212); Intermittent Loss of Power (4016)

Patient Problems Myocardial Infarction (1969); Vasoconstriction (2126); Foreign Body In Patient (2687)

Event Date 04/05/2021

Event Type  Death  

Event Description

It was reported that the rotaburr became stuck within the lesion, the rotaburr and rotawire were difficult to remove, the procedure was aborted, the patient went to surgery then later died during surgery.A 2.00mm peripheral rotalink plus atherectomy catheter burr and a peripheral rotawire guidewire were selected for use in a tibial atherectomy procedure.The patient was being treated at an outpatient facility.The 100% stenosed target lesion was located in the mildly tortuous and severely calcified peroneal artery.The devices were advanced to the lesion and atherectomy was performed with a set rotational speed of 180,000rpm.The burr stalled and became lodged into the peroneal artery.The burr could not be removed from the peroneal artery.At the time the burr became stuck in the peroneal artery the patient experienced a vasospasm which may have played a role in the burr becoming stuck within the peroneal artery.The procedure was cancelled and the patient was transferred via an ambulance to the hospital to have the devices removed surgically.The peripheral rotawire guidewire was removed but the patient experienced a cardiac event including myocardial infarction.During the burr removal, the patient died.The burr was not recovered.There was no postmortem performed on the patient.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis.The sheath, burr, and coil were microscopically and visually examined.Inspection of the device revealed that the coil and sheath were cut off at the burr housing strain relief.The portion of the coil and sheath that was cut off was reported to have been stuck within patient anatomy and was not returned for analysis.The rota wire used in the procedure was not returned for analysis, so a test wire was used.Functional testing was performed by attempting to advance the test wire through the burr housing and the advancer, and the test wire was able to be inserted without issues.Functional testing was then performed by connecting the rotalink plus to the rotablator console.During functional testing, the device was able to run and reach optimal speed with no issues.Product analysis could not confirm the reported event due to the sheath, coil, and burr having been cut off at the burr housing strain relief and not returned for analysis.However, the condition of the returned device matches the description as the coil and sheath were reported to have been cut due to difficulties in removing the burr from the patient.

Event Description

It was reported that the rotaburr was stuck on the lesion and the rotawire, was removed through surgery and patient expired.The 100% stenosed target lesion was located in the mildly tortuous and severely calcified peroneal artery.A 2.00mm peripheral rotalink plus and a peripheral rotawire were selected for use at an outpatient facility.During procedure, with the rotational speed set at 180,000rpm, it was noted that the burr stalled and became lodged into the peroneal artery.Furthermore, the burr could not be removed.Physician's comment was vasospasm played a role in the stuck burr.Consequently, the patient was transferred via ambulance to the hospital and the devices were removed as a unit through surgery and the surgeon cut the device at the plastic housing with scissors.The procedure was cancelled/rescheduled and patient was admitted to the hospital beyond standard of care.Patient expired post surgery to remove the burr and myocardial infarction.The burr was never recovered.There was no postmortem done on 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: 11726889
• MDR Text Key: 247354141
• Report Number: 2134265-2021-05019
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 08714729838920
• UDI-Public: 08714729838920
• 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: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/02/2023
• Device Model Number: 29720
• Device Catalogue Number: 29720
• Device Lot Number: 0026740024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Date Manufacturer Received: 05/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 64