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

Model Number H749236310040

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem ST Segment Depression (2487)

Event Date 10/24/2016

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).

Event Description

Same case as 2134265-2016-10350.It was reported that the patient experienced st segment drop.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified mid left anterior descending (lad) artery.During percutaneous coronary intervention (pci), a 2.0mm x 15mm emerge¿ balloon catheter was inserted after advancing a non bsc guide wire to the target lesion.However, the balloon failed to cross the lesion.Subsequently, a non bsc extra back up (ebu) guide catheter was used for another attempt to reinsert the balloon; however, the device still failed to cross the lesion.Furthermore, the physician attempted to advance a non bsc balloon catheter to the target lesion; however the device also failed to cross.The physician opted to perform rotablation with a rotawire and a 1.75mm rotalink¿ plus; however, patient¿s st segment dropped and condition became unstable.Consequently, due to prolonged procedure time, the physician decided to reschedule for another procedure.No further patient complications were reported and the patient¿s condition is stable.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.Returned product consisted of the rotalink plus device.The advancer unit and burr unit were received attached together as a single unit.The advancer knob was received tightened in a backward position.The advancer, burr, sheath, coil, and handshake connections were microscopically and visually examined.The annulus was damaged and not rounded.Functional testing was performed by connecting the device to the rotablator control console system.The device was unable to get any speed and the stall light came on.The advancer was dismantled and the turbine was found to be corroded 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 root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu.(b)(4).

Event Description

Same case as 2134265-2016-10350.It was reported that the patient experienced st segment drop.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified mid left anterior descending (lad) artery.During percutaneous coronary intervention (pci), a 2.0mm x 15mm emerge¿ balloon catheter was inserted after advancing a non bsc guide wire to the target lesion.However, the balloon failed to cross the lesion.Subsequently, a non bsc extra back up (ebu) guide catheter was used for another attempt to reinsert the balloon; however, the device still failed to cross the lesion.Furthermore, the physician attempted to advance a non bsc balloon catheter to the target lesion; however the device also failed to cross.The physician opted to perform rotablation with a rotawire and a 1.75mm rotalink¿ plus; however, patient¿s st segment dropped and condition became unstable.Consequently, due to prolonged procedure time, the physician decided to reschedule for another procedure.No further patient complications were reported and the patient¿s condition is 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: 6110934
• MDR Text Key: 60280335
• Report Number: 2134265-2016-10178
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729228370
• UDI-Public: (01)08714729228370(17)20180430(10)19245605
• 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,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Model Number: H749236310040
• Device Catalogue Number: 23631-004
• Device Lot Number: 19245605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2016
• Initial Date FDA Received: 11/17/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2016
• 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
• Treatment: BALLOON CATHETER: EMERGE2.0*15; BALLOON CATHETER: IKAZUCHI 1.0*6; GUIDE CATHETER: EBU GC; GUIDEWIRE: SION
• Patient Outcome(s): Hospitalization
• Patient Age: 69 YR