MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK ROTALINK¿ PLUS; CATHETER, CORONARY, ATHERECTOMY

Model Number H749236310030

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/11/2018

Event Type  Injury  

Manufacturer Narrative

Age at time of event: older than 18 years.(b)(4).

Event Description

It was reported that burr tip detachment occurred.The 90% stenosed target lesion was located in the severely tortuous and severely calcified proximal right coronary artery (rca).A 1.50mm rotalink¿ plus was selected for use.During procedure, an unspecified wire passed through the target lesion and a microcatheter was inserted under a 7fr guidezilla.After replacing the wire to rotawire, ablation was performed using 1.5mm burr which started at a rotational speed of 180,000rpm.Ablation was done at the calcified lesion of the tortuous part for about 3 times and then the lesion was crossed.However, upon crossing the tortuous lesion, an unusual sound was heard and the rotation speed decreased temporarily by 30,000rpm.When the burr was returned to platform speed, and the physician intended to end the rotablation; it was noted that the tip part of the burr became detached and remained in the distal part of the lesion.The rotawire was then pulled and the tip was grabbed with a snare; the detached tip was then successfully delivered into the guidezilla on the second attempt and was removed from the patient¿s body.As per physician¿s opinion, the burr shaft received resistance at the calcified tortuous part, and a gap occurred between the rotation speed of the shaft part and the rotation speed of the tip part which caused it twisting off.The procedure was not completed due to unavailability of same device.No further patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis.Returned product consisted of the rotablator rotalink plus device.The advancer unit and burr unit were received together.The burr housing was received dismantled.A rotawire was returned with the burr on it.The advancer, coil, sheath, handshake connections, burr, and annulus were microscopically and visually examined.The burr is separated from the coil and was received on the returned rotawire, the burr was removed from the wire with some resistance.The annulus is damaged/not rounded.This type of damage is consistent with damage caused by the interaction of a guidewire.The coil is stretched and broken.Functional testing could not be performed for guidewire difficulty due to the burr not being attached to the coil.Functional testing was performed by connecting the advancer to the rotablator control console system.There were no abnormal noises or leaks and the device did not run; so it wasn¿t able to get any speed.The advancer was dismantled and the ultem was found to be melted and the turbine is corroded.Inspection of the remainder of the device presented no other damage or irregularities.The investigation conclusion is user/use error as there was an act or omission of an act that resulted in a different medical device response than intended by the manufacturer or expected by the user; dfu states: ¿never operate the rotablator advancer without saline infusion.Flowing saline is essential for cooling and lubricating the working parts of the advancer.Operation of the advancer without proper saline infusion may result in permanent damage to the advancer¿.(b)(4).

Event Description

It was reported that burr tip detachment occurred.The 90% stenosed target lesion was located in the severely tortuous and severely calcified proximal right coronary artery (rca).A 1.50mm rotalink plus was selected for use.During procedure, an unspecified wire passed through the target lesion and a microcatheter was inserted under a 7fr guidezilla.After replacing the wire to rotawire, ablation was performed using 1.5mm burr which started at a rotational speed of 180,000rpm.Ablation was done at the calcified lesion of the tortuous part for about 3 times and then the lesion was crossed.However, upon crossing the tortuous lesion, an unusual sound was heard and the rotation speed decreased temporarily by 30,000rpm.When the burr was returned to platform speed, and the physician intended to end the rotablation; it was noted that the tip part of the burr became detached and remained in the distal part of the lesion.The rotawire was then pulled and the tip was grabbed with a snare; the detached tip was then successfully delivered into the guidezilla on the second attempt and was removed from the patient¿s body.As per physician¿s opinion, the burr shaft received resistance at the calcified tortuous part, and a gap occurred between the rotation speed of the shaft part and the rotation speed of the tip part which caused it twisting off.The procedure was not completed due to unavailability of same device.No further patient complications were reported.

• Brand Name: ROTALINK¿ PLUS
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer (Section G): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7642311
• MDR Text Key: 112488735
• Report Number: 2134265-2018-05859
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/11/2018

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: 11/04/2019
• Device Model Number: H749236310030
• Device Catalogue Number: 23631-003
• Device Lot Number: 0021463570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/11/2018
• Initial Date FDA Received: 06/27/2018
• Supplement Dates Manufacturer Received: 07/17/2018
• Supplement Dates FDA Received: 08/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GUIDE CATHETER- 7FR GUIDEZILLA; GUIDEWIRE- ROTAWIRE
• Patient Outcome(s): Required Intervention