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

Model Number H802227680030

Device Problem Entrapment of Device (1212)

Patient Problems Chest Pain (1776); Dyspnea (1816)

Event Date 08/27/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Same case as mdr id 2134265-2015-06397, 2134265-2015-06399.It was reported that the rota burr was stuck on the rotawire and patient experienced chest pain and dyspnea.A 330cm rotawire, rotalink¿ advancer and 1.50mm rotalink¿ burr were selected to treat the severely calcified target lesion located in the mid left anterior descending artery (lad).During the procedure, inside patient, it was noted that the rota burr was stuck with the rota wire and the advancer could not be moved in and out.The physician was able to remove the burr and the wire together as a unit after several attempts.However, due to the long time of procedure, the patient experienced chest pain and difficulty breathing.The procedure was completed with a different device.No further patient complications were reported and the patient's condition is stable.

Manufacturer Narrative

(b)(4).Device evaluated by mfr.: the complaint unit was returned connected to the advancer.A related guidewire was returned inserted in the catheter unit and was removed from the device with difficulty.A kink was visible in the mid-section of the related guidewire.Visual examination of the complaint unit was carried out and no issues were noted.The handshake connection was inspected and no damage was noted.A handshake connection test and a tug test was performed and no issues were noted.The complaint unit was wet tested using the related advancer.The complaint rotablator system did not reach any speed due to the melted ultem in the related advancer unit.The complaint unit was then wet tested using a test advancer unit and the device reached the required speed of 175krpm at 38psi.No functional issue was noted during the wet test of the catheter unit.The burr was microscopically examined and no issues were noticed with the annulus of the burr.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).

Event Description

Same case as mdr id 2134265-2015-06397, 2134265-2015-06399.It was reported that the rota burr was stuck on the rotawire and patient experienced chest pain and dyspnea.A 330cm rotawire, rotalink¿ advancer and 1.50mm rotalink¿ burr were selected to treat the severely calcified target lesion located in the mid left anterior descending artery (lad).During the procedure, inside patient, it was noted that the rota burr was stuck with the rota wire and the advancer could not be moved in and out.The physician was able to remove the burr and the wire together as a unit after several attempts.However, due to the long time of procedure, the patient experienced chest pain and difficulty breathing.The procedure was completed with a different device.No further patient complications were reported and the patient's condition is stable.

• Brand Name: ROTALINK¿ BURR
• 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: 5078888
• MDR Text Key: 25854098
• Report Number: 2134265-2015-06398
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: CN
• 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
• Report Date: 08/27/2015

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: 11/30/2016
• Device Model Number: H802227680030
• Device Catalogue Number: 22768-003
• Device Lot Number: 0017534001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/27/2015
• Initial Date FDA Received: 09/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2014
• 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
• Patient Outcome(s): Other
• Patient Age: 65 YR