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

Model Number H749236310030

Device Problems Fluid/Blood Leak (1250); Hole In Material (1293); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the sheath was torn, saline leaked and the rotation speed became unstable.The target lesion was located in the left anterior descending artery.A 1.50mm rotalink¿ plus was selected for use.During the procedure, it was noted that after removing the rotaburr from the body, it was noted that there was a strong vibration or wobble in the advancer and perforation was noted in the system as cocktail was squirting out.Consequently, it was difficult to keep proper rotation speed.The console was adjusted to keep speed as needed.The procedure was completed with this device.No patient complications were reported.

Manufacturer Narrative

Updated device evaluated by mfr., eval summary attached, method codes, result codes, and conclusion codes.Device evaluated by manufacturer: the device was returned for analysis.Returned product consisted of the rotablator rotalink plus device.The advancer unit and burr unit were received together.The handshake connection, sheath, coil and burr were microscopically and visually examined.The sheath is kinked in numerous locations.There is a severe kink in the sheath 21cm from the strain relief where the sheath also has small perforations and is leaking fluid.The coil is stretched.Microscopic examination of the device revealed that the annulus was damaged and not rounded which is consistent with damage seen with the use of a rotawire.Examination of the remainder of the device presented no other damage or irregularities.Functional testing was performed by connecting the rotablator rotalink plus device to the rotablator control console system.The rotablator system was able to reach optimum speed and the burr rotated with no issues.The investigation conclusion is handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact.(b)(4).

Event Description

It was reported that the sheath was torn, saline leaked and the rotation speed became unstable.The target lesion was located in the left anterior descending artery.A 1.50mm rotalink¿ plus was selected for use.During the procedure, it was noted that after removing the rotaburr from the body, it was noted that there was a strong vibration or wobble in the advancer and perforation was noted in the system as cocktail was squirting out.Consequently, it was difficult to keep proper rotation speed.The console was adjusted to keep speed as needed.The procedure was completed with this 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
• MDR Report Key: 7655040
• MDR Text Key: 112891495
• Report Number: 2134265-2018-05862
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729228363
• UDI-Public: 08714729228363
• 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,health
• Type of Report: Initial,Followup
• Report Date: 06/08/2018

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: 09/02/2019
• Device Model Number: H749236310030
• Device Catalogue Number: 23631-003
• Device Lot Number: 0021200170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2018
• Initial Date Manufacturer Received: 06/08/2018
• Initial Date FDA Received: 07/02/2018
• Supplement Dates Manufacturer Received: 07/16/2018
• Supplement Dates FDA Received: 08/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR