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

Model Number H80222782001A0

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/06/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Age at time of event: 18 years or older.(b)(4).

Event Description

It was reported that the wire could not be locked.A rotalink advancer was selected for use.During procedure, it was noted that the rotawre could not be locked.The procedure was completed with another of the same device and the patient's condition was stable.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The advancer knob was received tightened in a mid-way position.The brake, advancer and the handshake connection were microscopically and visually inspected.There was no damage or irregularities or damage to the device.The brake was able to be pressed and depressed with no issues.The guidewire used in the procedure was not returned for product analysis.A test.009¿ rotawire and wireclip torque were used for functional testing.The test guidewire and wireclip were attached to advancer with no issues.The advancer device was hooked up to the rotablator control console system.When the foot pedal was pressed, the advancer device was not able to get any speed and the stall light came on.The advancer was dismantled and the turbine was found to be corroded and the ultem was found to be melted.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.No other issues were identified during product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause was unable to be determined.(b)(4).

Event Description

It was reported that the wire could not be locked.A rotalink¿ advancer was selected for use.During procedure, it was noted that the rotawre could not be locked.The procedure was completed with another of the same device and the patient's condition was stable.

• Brand Name: ROTALINK¿ ADVANCER
• 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: 6221293
• MDR Text Key: 63821547
• Report Number: 2134265-2016-12202
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729317739
• UDI-Public: (01)08714729317739(17)20180430(10)19304385
• 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,Followup
• Report Date: 12/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Model Number: H80222782001A0
• Device Catalogue Number: 22782-001A
• Device Lot Number: 19304385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2016
• 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