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

Model Number H749236310020

Device Problem Activation Problem (4042)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/20/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Returned product consisted of the rotablator rotalink burr catheter for this device; however, the rotablator rotalink advancer for this device was not returned for analysis.The batch number on the returned burr catheter was 22119651.The handshake connection, sheath, coil, and burr were microscopically and visually examined.There was blood present inside the sheath, when received.There was a bent in the sheath 22.5cm distal of the strain relief.Microscopic examination showed the sheath was torn/split at the bend.The split/torn shaft is consistent to damage caused by the hemostasis valve being over tightened.As the advancer for this device was not returned for analysis, functional testing was performed with a test advancer.The advancer was hooked up to the rotablator control console system.The device ran with no issues but the sheath leaked where it was torn/split.Inspection of the remainder of the device presented no other damage or irregularities.The investigation conclusion is user / use error as there was an act or omission of an act that resulted in a different medical device response than intended by the manufacturer or expected by the user.It was reported that the consoled showed 190000-200000rpm and the physician started the procedure.The rotablator directions for use (dfu) includes the following related to the operating speed: "recheck the rational speed reading to verify that the rotation rate is appropriate for the burr size and lesion type, and adjust the operating speed.1.25 ¿ 2.0mm burrs 160,000 up to 180,000 rpm.¿ there was blood found in the sheath during analysis.Blood in the sheath indicates that there was not a continuous flow of saline during the procedure.A melted ultem is due to the interruption of saline or by insufficient flow of saline used during the preparation or during the procedure of the device.Saline is used in the clinical setting to cool and lubricate the moving parts and prevents a melted ultem, ensuring the functional use of the device.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 analysis completed on august 19, 2018.It was reported that the device failed to ablate the lesion and it stalled.A rotalink¿ plus was selected for use for a percutaneous coronary intervention (pci).The burr was guided on the wire and into the left main (lm) coronary artery where an rpm check was done.The console showed 190000-200000rpm.The physician started the procedure with a picking motion technique but saw no progress.The physician repeated this process 2-3x but the burr didn¿t bore.Therefore the burr was pushed back again into the lm to do another check but the console showed "stalled" while in the healthy lm.Hereafter the physician changed the burr from 1.25mm to 1.50mm and the procedure could be completed without any occurrences.No patient complications were reported.The patient condition after the procedure was stable.However, device analysis revealed a torn/split sheath.

• 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: 7874364
• MDR Text Key: 120245925
• Report Number: 2134265-2018-07436
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729316411
• UDI-Public: 08714729316411
• Combination Product (y/n): N
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/19/2018

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: 04/14/2020
• Device Model Number: H749236310020
• Device Catalogue Number: 23631-002
• Device Lot Number: 22119651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/19/2018
• Initial Date FDA Received: 09/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2018
• 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