MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) ROTAWIRE¿ AND WIRECLIP¿ TORQUER; CATHETER, CORONARY, ATHERECTOMY

Model Number H802228240022

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 2134265-2015-06398, 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

Device evaluated by mfr.: the complaint device was returned for analysis.A visual inspection of the device revealed a wire kinked in the middle of the device and the distal tip kinked.Dimensional inspection revealed that the device was within specification.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause classification of this investigation is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

Same case as mdr id 2134265-2015-06398, 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: ROTAWIRE¿ AND WIRECLIP¿ TORQUER
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5078857
• MDR Text Key: 25853458
• Report Number: 2134265-2015-06397
• 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,Followup
• 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: 03/09/2016
• Device Model Number: H802228240022
• Device Catalogue Number: 22824-002
• Device Lot Number: 16804926
• 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
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2014
• 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