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

Model Number H749236310020

Device Problems Thermal Decomposition of Device (1071); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/20/2017

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).

Event Description

It was reported that the burr became detached and smoke came out.The target lesion was located in the diagonal branch artery.A 1.25mm rotalink plus was selected for use.During preparation, the burr was not yet loaded on the rotawire when the rotation speed of the device was tested outside patient's body.Furthermore, the physician made test run at 150,000 rpm and it was noted that the burr became detached from the shaft and smoke came out from the friction of the burr and shaft.No patient complications were reported and the patient's status was stable.

Manufacturer Narrative

Device evaluated by mfr.The device was returned for evaluation.The advancer, handshake connection, coil and sheath were microscopically and visually examined.The advancer unit and burr devices were received attached together as a single unit.The advancer knob was received tightened in a backward position.The burr was detached from the coiled shaft.The burr was not returned for analysis.The separated end of the coil was stretched, which indicates removal force may have contributed to the separation.Functional testing was performed by connecting the rotablator rotalink plus device to the rotablator control console system.The device was not able to get any speed and the stall light came.The advancer was dismantled and the ultem was found to be melted and the turbine was corroded.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred without direct patient contact.Bsc id: (b)(4).Tw#: (b)(4).

Event Description

It was reported that the burr became detached and smoke came out.The target lesion was located in the diagonal branch artery.A 1.25mm rotalink¿ plus was selected for use.During preparation, the burr was not yet loaded on the rotawire when the rotation speed of the device was tested outside patient's body.Furthermore, the physician made test run at 150,000rpm and it was noted that the burr became detached from the shaft and smoke came out from the friction of the burr and shaft.No patient complications were reported and the patient's status was stable.

Manufacturer Narrative

Updated device evaluated by mfr.Device evaluated by mfr: a photo from the clinical procedure was further provided for review of the burr that was not returned.A review of the photo concluded that the burr was detached.(b)(4).

Event Description

It was reported that the burr became detached and smoke came out.The target lesion was located in the diagonal branch artery.A 1.25mm rotalink¿ plus was selected for use.During preparation, the burr was not yet loaded on the rotawire when the rotation speed of the device was tested outside patient's body.Furthermore, the physician made test run at 150,000rpm and it was noted that the burr became detached from the shaft and smoke came out from the friction of the burr and shaft.No patient complications were reported and the patient's status was stable.

• 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: 6708800
• MDR Text Key: 79954671
• Report Number: 2134265-2017-06907
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729316411
• UDI-Public: (01)08714729316411(17)20181130(10)20026343
• Combination Product (y/n): N
• Reporter Country Code: SG
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/23/2017

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: 11/30/2018
• Device Model Number: H749236310020
• Device Catalogue Number: 23631-002
• Device Lot Number: 20026343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/23/2017
• Initial Date FDA Received: 07/12/2017
• Supplement Dates Manufacturer Received: 07/15/2017; 08/09/2017
• Supplement Dates FDA Received: 08/02/2017; 08/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2016
• 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