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

Model Number H749236310040

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/08/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Same case as mdr id: 2134265-2017-13098.It was reported that the tip of the rotawire was rotating inside the blood vessel.The target lesion was located in the severely calcified left main trunk.A 1.75mm rotalink¿ plus and a 330cm rotawire¿ were selected for use.During the procedure, a 0.014" non bsc guidewire was advanced to the target lesion and then a non bsc microcatheter was inserted and replaced with the rotawire.When the rotawire was advanced inside the guiding catheter in order to reach the 1.75mm rotaburr up to lesion by dynaglide, it was noted under fluoroscopy that the tip of the rotawire was found rotating in the blood vessel.Afterwards, the rotawire was slightly withdrawn and was advanced again through dynaglide mode.Ablation was then performed and was completed with the same rotalink and the same rotawire.No patient complications were reported.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.Returned product consisted of the rotablator rotalink plus device.The brake button, advancer, handshake connections, sheath, coil and burr were microscopically and visually inspected.Microscopic examination of the device revealed that the annulus was damaged and not rounded.The damage to the annulus is consistent with damage caused by contact with the rotawire during use.The brake button was received in the as-manufactured position.The brake button was tested and it was able to be pressed and released with no issues.The guidewire used in the procedure was not returned for product analysis, so functional testing was completed with a test rotawire.The rotawire was not able to be inserted in the annulus of the burr due to the damage, so the advancer and burr catheter were detached and the rotawire was inserted into the handshake connection of the advancer.Functional testing was performed by connecting the advancer device to the rotablator control console system and the brake was tested with the rotawire.The brake and rotawire worked properly with no issues.The advancer was opened and the brake was examined.There was no damage or irregularities to the brake or the inside the advancer at the brake location.Inspection of the remainder of the device presented no other damage or irregularities.The investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.(b)(4).

Event Description

Same case as mdr id: 2134265-2017-13098.It was reported that the tip of the rotawire was rotating inside the blood vessel.The target lesion was located in the severely calcified left main trunk.A 1.75mm rotalink¿ plus and a 330cm rotawire¿ were selected for use.During the procedure, a 0.014" non bsc guidewire was advanced to the target lesion and then a non bsc microcatheter was inserted and replaced with the rotawire.When the rotawire was advanced inside the guiding catheter in order to reach the 1.75mm rotaburr up to lesion by dynaglide, it was noted under fluoroscopy that the tip of the rotawire was found rotating in the blood vessel.Afterwards, the rotawire was slightly withdrawn and was advanced again through dynaglide mode.Ablation was then performed and was completed with the same rotalink and the same rotawire.No patient complications were reported.

• 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: 7141703
• MDR Text Key: 95795766
• Report Number: 2134265-2017-13099
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729228370
• UDI-Public: 08714729228370
• Combination Product (y/n): N
• 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: 12/08/2017

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: 09/09/2019
• Device Model Number: H749236310040
• Device Catalogue Number: 23631-004
• Device Lot Number: 0021231792
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2017
• Initial Date FDA Received: 12/22/2017
• Supplement Dates Manufacturer Received: 01/04/2018
• Supplement Dates FDA Received: 01/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2017
• 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