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

Model Number H749236310020

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported that foreign material was found on the burr.A 1.25mm rotalink¿ plus was selected for use.During preparation, while setting the speed, the burr was advanced forward; however, it was noted that the burr tangled up in a towel.Pieces of the towel and lint were observed on the burr.The burr was not placed in the patient.The procedure was completed with another of the same device.No patient complications were reported.

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the batch number is unknown and the manufacturing records for the complaint device could not be reviewed.The most probable root cause has been determined to be use/user error as the dfu states: ¿the burr at the distal tip of the rotalink catheter is capable of rotating at very high speed.Do not allow parts of the body or clothing to come in contact with the burr.Contact may result in physical injury or entanglement.¿ (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: 4940726
• MDR Text Key: 6253662
• Report Number: 2134265-2015-04778
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/29/2015

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 Model Number: H749236310020
• Device Catalogue Number: 23631-002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2015
• Initial Date FDA Received: 07/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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