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

Model Number H749236310040

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/09/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the device was leaking rotaglide.The target lesion was located in the left main trunk artery.A 1.75mm rotalink plus was selected for use.During procedure, it was noted that the rotaglide solution was leaking out of the sheath of the burr.Furthermore, a hole was noticed and the device was withdrawn from the patient's body.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was fine.

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 together by the handshake connections but the housings were not connected.The advancer knob was back and loose.The coil at the end of the handshake connection was kinked.The sheath was microscopically and visually inspected.There was blood in the sheath and a hole with damage 23.5cm from the strain relief on the catheter body housing.There were also numerous kinks throughout the sheath.Functional testing was performed by connecting the rotalink plus device to the rotablator control console system.When the drip line was turned on, water started leaking from the hole in the sheath.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

It was reported that the device was leaking rotaglide.The target lesion was located in the left main trunk artery.A 1.75mm rotalink¿ plus was selected for use.During procedure, it was noted that the rotaglide solution was leaking out of the sheath of the burr.Furthermore, a hole was noticed and the device was withdrawn from the patient's body.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was fine.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported via facility medwatch (b)(4) that the rotablator stalled inside patient's body.

• 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: 6137911
• MDR Text Key: 61244009
• Report Number: 2134265-2016-10909
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729228370
• UDI-Public: (01)08714729228370(17)20180831(10)19726813
• 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,Followup,Followup
• Report Date: 11/09/2016

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: 08/31/2018
• Device Model Number: H749236310040
• Device Catalogue Number: 23631-004
• Device Lot Number: 19726813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2016
• Initial Date FDA Received: 12/01/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/16/2016; 01/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2016
• 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