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

Model Number H749236310040

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/07/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Same case as mdr id: 2134265-2016-12003.It was reported that the rotawire fracture occurred.The 90% stenosed target lesion was located in the severely calcified and moderately tortuous left anterior descending artery.A 1.75mm rotalink¿ plus and a 330cm rotawire¿ were selected for use.During the procedure, a white string-like material was attached to the burr when tried to polish for the second time.A fragment of the wire was noted.The procedure was completed with another of the same device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr., eval summary attached, method codes, result codes, conclusion codes updated.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 received tightened in a backward position.The advancer, sheath, coil, and burr were microscopically and visually inspected.There was blood on the advancer unit housing.There was what appeared to be dried/crystalized saline and white fibrous material on the burr and coil; when received.There was no portion wire on the device or received with this device.The saline at the end of the burr was moved aside and the annulus was noticed to be damaged/not rounded.It is probable that the rotating burr came into contact with the guidewire during the procedure leading to the damaged annulus.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

Same case as mdr id: 2134265-2016-12003.It was reported that the rotawire fracture occurred.The 90% stenosed target lesion was located in the severely calcified and moderately tortuous left anterior descending artery.A 1.75 mm rotalink plus and a 330 cm rotawire were selected for use.During the procedure, a white string-like material was attached to the burr when tried to polish for the second time.A fragment of the wire was noted.The procedure was completed with another of the same device.No patient complications were reported.

• 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: 6192931
• MDR Text Key: 62992840
• Report Number: 2134265-2016-12002
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729228370
• UDI-Public: (01)08714729228370(17)20170531(10)18105441
• 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: 12/08/2016

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 Expiration Date: 05/31/2017
• Device Model Number: H749236310040
• Device Catalogue Number: 23631-004
• Device Lot Number: 18105441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2016
• Initial Date FDA Received: 12/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2015
• 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