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

Model Number H749236310020

Device Problems Air Leak (1008); Entrapment of Device (1212); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/19/2015

Event Type  malfunction  

Event Description

Same case as:2134265-2015-00830.It was reported that the burr became stuck on the wire.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified mid left anterior descending artery (lad).Pre-dilatation was performed; however, it was not enough so the physician opted to use rotational atherectomy.A 1.25mm rotalink¿ plus and an rotawire floppy were selected for use.During procedure, the rotation speed was set at 190,000rpm outside of the patient and the burr was delivered to the proximal lad.After ablation at 175,000rpm for 5 times, the burr was removed from the patient.An unspecified microcatheter was advanced however, it failed to reach the distal area of the lesion.The physician then decided to ablate the mid lad.The burr was then advanced and ablation was performed 4 times.However, the rotation speed became unstable.Starting speed was only at 150,000rpm and after reaching 175,000rpm it could not be increased further, although it was set at 190,000rpm.The speed was decreased by 5,000rpm each time.The physician attempted to ablate the lesion further, however, air leaking noise was observed from the burr.The rotation was stopped and the device was unable to change to dynaglide mode.The physician then attempted to remove the burr manually, however, the burr was stuck on the wire and did not move at all.Both the burr and the wire were removed as a unit and stenting was performed to complete the procedure.There were no patient complications reported and the patient's condition was good.

Event Description

It was further reported that the set speed was at 190,000rpm, however the device was not able to go over 175,000rpm and was not able to keep the rotation at one speed.

Manufacturer Narrative

(b)(6).Age at the time of event: 18 years or older.(b)(4).The rotablator rotalink plus 1.25mm unit was returned connected to the catheter.The related guidewire was returned inserted in the rotablator plus unit and could not be removed from the device.A visual examination of the complaint unit was carried out and no issues were noted.The advancer knob was locked upon return in a backward position; it was loosened and advanced in order to inspect the handshake connection.The handshake connection was inspected and no damage was noted.A handshake connection test and a tug test was attempted to examine the integrity of the connection.No issues were noted.The drive shaft, coil and sheath were inspected and there was no damage noted.The complaint unit was wet tested.The complaint rotablator system did not reach any speed.No unusual gas/air leak was noted during the attempt to wet test the device.The device was dismantled and a melted ultem was evident.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause has been determined to be use/user error as the 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).

Manufacturer Narrative

(b)(4).

• 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4511088
• MDR Text Key: 5536044
• Report Number: 2134265-2015-00468
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Model Number: H749236310020
• Device Catalogue Number: 23631-002
• Device Lot Number: 17375841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2014
• 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: GUIDEWIRE: ROTA FLOPPY