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

Model Number H749236310020

Device Problems Kinked (1339); Failure to Advance (2524)

Patient Problem Hematoma (1884)

Event Date 01/26/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Same case as mdr id: 2134265-2017-01354.It was reported that a femoral artery hematoma occurred and the patient became unstable.The 85% stenosed target lesion was located in the severely tortuous and severely calcified right coronary artery.A 1.25 mm rotalink plus and a rotawire were selected for treatment.During the procedure, it was noted that the burr was unable to pass because of the acute angulation which caused the rotawire to kink.A femoral artery hematoma suddenly occurred and the patient became unstable.The rotablation procedure was stopped and the devices were removed from the patient.Approximately several minutes later, percutaneous coronary intervention was performed on the simple lesion located in left anterior descending artery and the patient stabilized.The procedure was completed with a different device with no further events.No further patient complications were reported and the patient's condition was fine.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.Returned product consisted of the rotalink plus device.The advancer and burr units were received attached together as a single unit.The advancer knob was received loosened in a midway position.The advancer, burr, sheath, coil, and handshake connections were microscopically and visually examined.The annulus was damaged, not rounded and flattened.Functional testing was performed by connecting the rotalink plus device to the rotablator control console system.The device was not able to get any speed and the stall light came on the console.The advancer was dismantled and the ultem was found to be melted.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 operational context as device performance was limited due to anatomical/procedural factors.(b)(4).

Event Description

Same case as mdr id: 2134265-2017-01354.It was reported that a femoral artery hematoma occurred and the patient became unstable.The 85% stenosed target lesion was located in the severely tortuous and severely calcified right coronary artery.A 1.25mm rotalink¿ plus and a rotawire were selected for treatment.During the procedure, it was noted that the burr was unable to pass because of the acute angulation which caused the rotawire to kink.A femoral artery hematoma suddenly occurred and the patient became unstable.The rotablation procedure was stopped and the devices were removed from the patient.Approximately several minutes later, percutaneous coronary intervention was performed on the simple lesion located in left anterior descending artery and the patient stabilized.The procedure was completed with a different device with no further events.No further patient complications were reported and the patient's condition 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: 6345906
• MDR Text Key: 67857071
• Report Number: 2134265-2017-01063
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729316411
• UDI-Public: (01)08714729316411(17)20180930(10)19842620
• Combination Product (y/n): N
• Reporter Country Code: KR
• 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
• Report Date: 01/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: H749236310020
• Device Catalogue Number: 23631-002
• Device Lot Number: 19842620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2016
• 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
• Patient Outcome(s): Other
• Patient Age: 72 YR