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

Model Number H802227680030

Device Problem Kinked (1339)

Patient Problem No Patient Involvement (2645)

Event Date 11/18/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was returned for evaluation.The handshake connection, sheath, coil, and burr were microscopically and visually examined.Inspection of the device observed a kink in the coil at the handshake connection.The coil was pulled out of the housing about 20cm.At the distal end of the catheter, the coil was stretched and broken with the burr detached.The burr was not returned for analysis.The sheath was torn at the distal end.The end of the sheath was jagged and damaged, which indicates that the tensile overload was involved.Functional testing was done with a test rotawire; however, it was not able to be inserted through the broken coil or the kinked coil.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.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

Reportable based on device analysis completed on (b)(6) 2018.It was reported that a kink on the burr catheter occurred.The target lesion was located in the left anterior descending artery (lad).A 1.50mm rotalink burr was selected for use.Upon introduction, outside patient's body, a kink in the burr catheter was noted while attaching the burr and the advancer.The procedure was completed with another of the same burr.No patient complications reported.However, device analysis revealed that the burr was detached and missing.

• 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: 7217157
• MDR Text Key: 98295264
• Report Number: 2134265-2018-00247
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729185857
• UDI-Public: 08714729185857
• 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,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/24/2019
• Device Model Number: H802227680030
• Device Catalogue Number: 22768-003
• Device Lot Number: 20806098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2017
• 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