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

Model Number H749236310040

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis (2100)

Event Date 04/26/2018

Event Type  Injury  

Manufacturer Narrative

Age at time of event: 18 years or older.Device evaluated by manufacturer: the device was returned for analysis.Visual and microscopic examination of the advancer, handshake connections, coil, sheath, and burr were performed and revealed that the annulus of the burr was damaged and not rounded.Also, there were fibers on the coil at the end of the burr.The burr was measured with a calibrated snap gauge and the burr measured to be a 1.75mm burr and was within specification.Since the guide catheter used in the procedure was not returned for product analysis and the inner diameter of the guide catheter was not reported, functional testing was completed with a test 6f (id of 0.070¿) and a 7f (id of.081¿) guide catheter.The rotablator rotalink plus device was able to be inserted and advanced through both guide catheters with no resistance.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.(b)(4).

Event Description

It was reported that patient experienced thrombosis.The 75% stenosed target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 1.75mm rotalink¿ plus was selected for use.During introduction, the burr was delivered inside the guiding catheter by dynaglide, but resistance was felt in the mid-way and so the dynaglide was stopped.The burr was then pushed by hand to advance, however severe resistance was met.Gradually, a thrombus like tissue in the left main trunk around the end of the guiding catheter was confirmed by intravascular ultrasound (ivus) under angiography.The thrombus was pressed against the blood vessel wall using a stent and the burr was simply pulled out from the patient's body.The procedure was not complete due to the event.No further patient complications were reported and patient's status was stable.

• 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: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7537515
• MDR Text Key: 109042150
• Report Number: 2134265-2018-04566
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729228370
• UDI-Public: 08714729228370
• Combination Product (y/n): N
• 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: 05/01/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/21/2019
• Device Model Number: H749236310040
• Device Catalogue Number: 23631-004
• Device Lot Number: 0021409228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/01/2018
• Initial Date FDA Received: 05/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2017
• 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