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

Model Number H749236310030

Device Problems Defective Component (2292); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/20/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Age at time of event: 18 years or older.Device evaluated by mfr.: device was returned for analysis.On visual inspection it was noted that the catheter sheath was damaged.The advancer knob upon return was in a midways position; it was advanced in order to inspect the handshake connection.The handshake connection was inspected and the no issues were noted.A handshake connection test was attempted to examine the integrity of the connection and no issues were noted.The drive shaft and coil were inspected and there was no damage noted.An attempt was made to functionally test the complaint unit, however, no speed was achieved.The device was dismantled and a melted ultem was evident.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: ¿never operate the rotablator advancer without saline infusion.Flowing saline is essential for cooling and lubricating the working parts of the advancer.Operation of the advancer without proper saline infusion may result in permanent damage to the advancer.¿ (b)(4).

Event Description

Reportable based on device analysis completed on 01jun2016.It was reported that sheath damaged and not reaching optimum speed occurred.The 90% stenosed target lesion was located in the severely tortuous and severely calcified proximal left anterior descending artery.A 1.50mm rotalink¿ plus was used to treat the target lesion.The device was prepared and rotational speed was set up outside the patient.An attempt was made to set the rotational speed to 190,000 rpm, but it stopped increasing at 175,000 rpm and gradually decreased to 130,000 rpm.Setting up of speed was stopped and the device was checked, and it was noted that the drive shaft sheath was damaged.The procedure was completed with another 1.50mm rotalink¿ plus.No patient complications reported and patient condition was good.However, device analysis revealed that the sheath was torn/split.

• 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: 5756111
• MDR Text Key: 48403797
• Report Number: 2134265-2016-05483
• 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
• Report Date: 06/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Model Number: H749236310030
• Device Catalogue Number: 23631-003
• Device Lot Number: 17761860
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2015
• 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