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

Model Number H749236310020

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/19/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

Same case as mdr id: 2134265-2017-07815.It was reported that there were air bubbles at the burr.A 1.25mm rotalink plus were selected for use.Upon platforming, outside patient's body, saline leak was noted on the advancer and bubbles went up to the burr.In addition, the sleeve of the connection was noted to be loose when the device was checked and the physician suspected that the connection between the burr and the motor was not hermetically closed.The device was replaced with another of the same rotalink device; however the same issue occurred.The procedure was not completed due to the event.There were no patient complications reported and the patient's condition was stable.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The advancer, coil, sheath, handshake connections, burr, and annulus were microscopically and visually examined.The advancer unit and burr unit were received attached together as a single unit; however, the housing for the burr catheter was received detached and the sheath was kinked and the burr handshake connection was bent.The advancer knob was loosened and the handshake connections were checked.The handshake connection for the advancer was also damaged.The annulus of the burr was damaged and not rounded.The damage to the annulus is consistent with damage caused by contact with the rotawire during use.Functional testing was performed by connecting the rotalink plus device to the rotablator control console system.There were no abnormal noises, leaks, and the device did not run; so it wasn't able to get any speed.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.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: 2134265-2017-07815.It was reported that there were air bubbles at the burr.A 1.25mm rotalink¿ plus were selected for use.Upon platforming, outside patient's body, saline leak was noted on the advancer and bubbles went up to the burr.In addition, the sleeve of the connection was noted to be loose when the device was checked and the physician suspected that the connection between the burr and the motor was not hermetically closed.The device was replaced with another of the same rotalink device; however the same issue occurred.The procedure was not completed due to the event.There were no patient complications reported and the patient's condition 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: 6773945
• MDR Text Key: 82050570
• Report Number: 2134265-2017-07814
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729316411
• UDI-Public: (01)08714729316411(17)20190501(10)20710007
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 07/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2019
• Device Model Number: H749236310020
• Device Catalogue Number: 23631-002
• Device Lot Number: 20710007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2017
• 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