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

Model Number H749236310020

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/14/2013

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by manufacturer.The device was returned for analysis.It was observed that the burr was detached from the distal coil of the catheter unit and was stuck on the returned guidewire which was received separately from the device.The burr was removed from the guidewire with some difficulty.The distal coil of the catheter unit was stretched.No issues were noted with the unit¿s handshake connection.No issue was noted with the actual sheath of the catheter unit.A microscopic examination revealed the annulus of the burr was damaged and the proximal burr met specification.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

Reportable based on device analysis completed on (b)(4) 2014.Same case as mdr id # 2134265-2014-00097.It was reported that the catheter became kinked.The target lesion location is unknown.A 1.25mm rotalink plus was selected for a percutaneous coronary intervention procedure.During the procedure, it was noted that the catheter became kinked while it was being introduced into the patient's artery.A 1.5mm rotalink plus was then advanced, but it was noted to be bent.Another of the same device was then used to continue the procedure without issue.No patient complications were reported and the patient's status is fine.However, device analysis revealed that a burr detachment occurred.

• 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: ingrid matte ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 3595958
• MDR Text Key: 18566970
• Report Number: 2134265-2014-00082
• Device Sequence Number: 1
• Product Code: MCX
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2015
• Device Model Number: H749236310020
• Device Catalogue Number: 23631-002
• Device Lot Number: 0016384148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2013
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2013
• 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