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

Model Number H749236310020

Device Problem Air Leak (1008)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.Returned product consisted of the rotalink plus device.The advancer unit and burr unit were received attached together as a single unit.The advancer knob was returned tightened in a backward position.There were numerous kinks throughout the sheath.The sheath was split on both sides and flattened 46.75 ¿ 48cm proximal of the distal end of the sheath.The annulus was damaged, not rounded and flattened.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.Functional testing was performed by connecting the rotalink plus device to the rotablator control console system.When the drip line was turned on the sheath leaked at the split.The burr catheter was removed and the advancer was tested alone.The device was not able to get any speed and the stall light came on the console.The advancer was dismantled and the ultem was found to be melted.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).

Event Description

Reportable based on device analysis completed on 10-mar-2017.It was reported that the advancer was leaking air.A 1.25mm rotalink¿ plus was selected for use.During preparation at outside patient's body, it was noted that the advancer was leaking air.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was good.However, device analysis revealed a split sheath.

• 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: 6449075
• MDR Text Key: 71334065
• Report Number: 2134265-2017-02638
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729316411
• UDI-Public: (01)08714729316411(17)20181231(10)0020181638
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: H749236310020
• Device Catalogue Number: 23631-002
• Device Lot Number: 0020181638
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2017
• 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