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

Model Number H802227680020

Device Problems Kinked (1339); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/17/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by manufacturer: the device was returned for analysis.Returned product consisted of the rotalink burr catheter device.The burr, annulus, sheath, coil, and handshake connection were microscopically and visually examined.Majority of the coil was received kinked underneath the sheath.The handshake connection was received inside the housing and would not retract back out due to damage to the distal end of the sheath.The housing was dismantled and it was revealed that the handshake connection was stuck inside the sheath and the coil was kinked and stretched next to the handshake connection inside the sheath.The sheath had excessive wear inside the sheath at the location of the damaged coil and the handshake connection.The distal end of the sheath had a partial separation and was stretched and twisted.The sheath was pulled over the burr.The guidewire used in the procedure was not returned for product analysis, so functional testing was completed with a test rotawire.The rotawire would not advance pass the damaged coil.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.No other issues were identified during the product analysis.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

It as reported that the shaft was kinked and the burr will not load onto guidewire.A 1.25mm rotalink¿ burr was selected for use.During procedure while attaching the burr and advancer, it was noticed that there was a kink on the burr catheter.Consequently, the physician was not able to negotiate the burr over the wire.The procedure was completed with another of the same device.No patient complications were reported.However, device analysis revealed that the distal end of the sheath had a partial separation.

• Brand Name: ROTALINK¿ BURR
• 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: 6613120
• MDR Text Key: 76727074
• Report Number: 2134265-2017-05363
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729185864
• UDI-Public: (01)08714729185864(17)20181231(10)20160507
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2017
• 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: H802227680020
• Device Catalogue Number: 22768-002
• Device Lot Number: 20160507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2017
• 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