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

Model Number H749236310020

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/28/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr.: returned product consisted of the rotalink device.The advancer knob and handshake were microscopically and visually inspected.The handshake connections were visually examined.The sheath of the burr catheter was separated 113cm from the distal end of the sheath.The separated ends were jagged which indicates the separation may have been due to tesile forces applied.Functional testing was performed by connecting the advancer to the rotablator control console system.The device was not able to get any speed and the stall light came on.The advancer was dismantled and the ultem was found to be melted and the turbine was corroded.Inspection of the remainder of the device revealed no other damage or irregularities.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

Same case as mdr id# 2134265-2017-07135.It was reported that the sheath was torn.The target lesion was located in the left anterior descending (lad) artery.A 1.25mm rotalink¿ plus was advanced to perform ablation.The device was able to do two passes; however, on the third pass, the device kept stalling.The physician checked all the connections, including the drip and everything was fine.The device was removed from the patient's body and it was noted that the metal sheath that covers the spring on the rotablator was torn.Ablation was completed with a 1.5mm rotalink¿ plus.Following ablation, a 3.50x32mm promus premier¿ drug-eluting stent was advanced with a non-bsc guide extension catheter in place and two guide wires across the lesion.However, the device could not pass through the non-bsc guide extension catheter.The device was removed from the patient's body and the stent was noted to be shredded up.The procedure was completed with a different device.No patient complications were reported and the patient's status was fine.

• 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: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6722663
• MDR Text Key: 80420217
• Report Number: 2134265-2017-07127
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729316411
• UDI-Public: (01)08714729316411(17)20190331(10)20473067
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/28/2017

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: 03/31/2019
• Device Model Number: H749236310020
• Device Catalogue Number: 23631-002
• Device Lot Number: 20473067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/28/2017
• Initial Date FDA Received: 07/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2017
• 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
• Patient Age: 59 YR