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

Model Number H749236310020

Device Problems Entrapment of Device (1212); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/06/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the burr became stuck in the lesion and burr detachment occurred.The 99% stenosed target lesion was located in the severely tortuous and severely calcified proximal right coronary artery (rca).A 1.25mm rotalink¿ plus was selected for use.During the procedure, a non bsc balloon catheter failed to cross the target lesion.The non bsc balloon was then replaced with a 1.25mm rotalink¿ plus and a rotawire and the rotalink¿ plus was used initially at 190,000rpm.However, it was noted that the burr became stuck in the narrow stenosis of the target lesion.The physician removed his foot from the foot pedal and it did not rotate at first.Then, the physician tried to remove the burr and the rotawire together with the non bsc guide catheter by pulling for 5 to 10 minutes with force.When it was taken outside the patient's body, it was noted that the joint part of the burr and shaft got separated.The rotawire floppy remained in the boundary of the radiopaque marker and opaque and the burr was in free condition along the rotawire.The device was able to be successfully retrieved.The procedure was not completed and treatment was to be prescribed again.No further patient complications were reported and the patient's status was stable.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The advancer, handshake connections, sheath, coil, and burr were microscopically and visually examined.The coil was received broken and stretched.The burr was detached from the coil and received on the rotawire.The burr was not able to be removed from the rotawire, as the wire could not be removed from the rotablator due to the damage associated with the rotawire.Inspection of the burr revealed that the annulus was damaged and flared.The damage to the annulus is consistent to interaction with the rotawire during rotation.There was also damage to the bottom of the burr and there was portion of the coil still attached inside the burr.It¿s probable that the damage to the coil and bottom of the burr was associated to pulling on the device when the burr was stuck in the lesion for 5 to 10 minutes with force, as reported.Inspection of the remainder of the device, apart from the observed damage, revealed 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.The dfu states: "recheck the rational speed reading to verify that the rotation rate is appropriate for the burr size and lesion type, and adjust the operating speed.1.25 ¿ 2.0mm burrs 160,000 up to 180,000 rpm¿.(b)(4).

Event Description

Same case as mdr id: 2134265-2018-00367.It was reported that the burr became stuck in the lesion and burr detachment occurred.The 99% stenosed target lesion was located in the severely tortuous and severely calcified proximal right coronary artery (rca).A 1.25mm rotalink plus was selected for use.During the procedure, a non bsc balloon catheter failed to cross the target lesion.The non bsc balloon was then replaced with a 1.25mm rotalink plus and a rotawire and the rotalink plus was used initially at 190,000rpm.However, it was noted that the burr became stuck in the narrow stenosis of the target lesion.The physician removed his foot from the foot pedal and it did not rotate at first.Then, the physician tried to remove the burr and the rotawire together with the non bsc guide catheter by pulling for 5 to 10 minutes with force.When it was taken outside the patient's body, it was noted that the joint part of the burr and shaft got separated.The rotawire floppy remained in the boundary of the radiopaque marker and opaque and the burr was in free condition along the rotawire.The device was able to be successfully retrieved.The procedure was not completed and treatment was to be prescribed again.No further patient complications were reported and the patient's status was stable.

• 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: 7137773
• MDR Text Key: 95666173
• Report Number: 2134265-2017-13000
• 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,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Model Number: H749236310020
• Device Catalogue Number: 23631-002
• Device Lot Number: 19523889
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2017
• Initial Date FDA Received: 12/21/2017
• Supplement Dates Manufacturer Received: 01/06/2018
• Supplement Dates FDA Received: 01/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2016
• 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