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

Model Number H749236310040

Device Problems Entrapment of Device (1212); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/08/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Same case as: 2134265-2016-01459.It was reported that the burr was stuck on wire and foreign material was noted.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified coronary artery.A 1.75mm rotalink¿ plus and a rotawire¿ were selected to treat target lesion.During withdrawal with dynaglide, it was noted that the rotawire and burr were stuck.The entire system had to be withdrawn.It was further noted that the rotawire was able to retract when it was outside the patient.Also, there was a fiber-like stuck near the shaft of the rotaburr when the burr was retracted.The procedure was completed with this device.No patient complications were reported and the patient's status was good.

Manufacturer Narrative

Corrected device lot number from 18567540 to 18398753.Corrected device expiration date from 09/30/2017 to 08/31/2017.Corrected device manufactured date from 10/29/2015 to 09/17/2015.Device evaluated by mfr: the complaint device was returned for evaluation.A visual examination of the complaint unit revealed that the handshake connection had no damage noted.Threads and fibers were noted to be wrapped around the coil of the catheter.The burr was microscopically examined and no issue was noted with the annulus of the burr.No issues were noted with the exposed brass on the plated back half of the burr.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause has been determined to be use/user error as the dfu states: ¿the burr at the distal tip of the rotalink catheter is capable of rotating at very high speed.Do not allow parts of the body or clothing to come in contact with the burr.Contact may result in physical injury or entanglement.¿ (b)(4).

Event Description

Same case as: 2134265-2016-01459.It was reported that the burr was stuck on wire and foreign material was noted.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified coronary artery.A 1.75mm rotalink plus and a rotawire were selected to treat target lesion.During withdrawal with dynaglide, it was noted that the rotawire and burr were stuck.The entire system had to be withdrawn.It was further noted that the rotawire was able to retract when it was outside the patient.Also, there was a fiber-like stuck near the shaft of the rotaburr when the burr was retracted.The procedure was completed with this device.No patient complications were reported and the patient's status was good.

• 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5484262
• MDR Text Key: 39807408
• Report Number: 2134265-2016-01458
• Device Sequence Number: 1
• Product Code: MCX
• 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,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/08/2016

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: 08/31/2017
• Device Model Number: H749236310040
• Device Catalogue Number: 23631-004
• Device Lot Number: 18398753
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2016
• Initial Date FDA Received: 03/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2015
• 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