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

Model Number H749236310020

Device Problem Entrapment of Device (1212)

Patient Problem Discomfort (2330)

Event Date 01/07/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).It is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that the burr was stuck in the lesion.The target lesion was located in the left anterior descending artery (lad).A 1.25mm rotalink plus was selected for use.During the procedure, cutting balloons and other devices were used prior to rotablation.The advancer knob was checked before it was inserted to the patient and tightness was encountered in moving forward and backward.During rotablation, the advancer knob became tighter.As the device was advanced further, it was noted that the burr became stuck in the calcified lesion.After two attempts to advance the burr, the procedure was aborted and rescheduled for another date.The patient became very restless and uncomfortable as rotablation was started only two and a half hours later through the procedure.Dynaglide mode was activated and slowly disengaged the burr from the lesion and out of the patient's body.No further patient complications were reported and the patient's condition was ok.

• 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: 5392864
• MDR Text Key: 36890356
• Report Number: 2134265-2016-00219
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: SG
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/07/2016

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: 06/30/2017
• Device Model Number: H749236310020
• Device Catalogue Number: 23631-002
• Device Lot Number: 18200870
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/07/2016
• Initial Date FDA Received: 01/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2015
• 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