MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTALINK PLUS; CATHETER, CORONARY, ATHERECTOMY

Model Number 3241

Device Problems Peeled/Delaminated (1454); Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/17/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that the diamond coating peeled off.The target lesion area was located in a severely calcified left circumflex artery (lcx) and left descending artery (lad).A 1.25mm rotalink plus was selected for use.During the procedure, when the device came in contact with the lesion in the lad area, the rotation speed did not decrease.It was also noted that the diamond coating was peeled off.The device was simply pulled out while the burr was still rotating.The procedure was completed with another of the same device.No patient complications were reported and the patient's condition was good post procedure.

Manufacturer Narrative

E1 initial reporter facility name: (b)(6).Device evaluated by manufacturer: the returned complaint device consisted of a rotablator plus device.The burr catheter was attached to the advancer when received and the knob was in the locked middle location.The advancer, handshake connection, sheath, coil, burr and annulus were microscopically and visually examined.Visual examination revealed no damages.Microscopic examination revealed that the coil is stretched.Functional testing was performed by rotating the drive shaft and it was unable to rotate.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found no damage to the burr.

Event Description

It was reported that the diamond coating peeled off.The target lesion area was located in a severely calcified left circumflex artery (lcx) and left descending artery (lad).A 1.25mm rotalink plus was selected for use.During the procedure, when the device came in contact with the lesion in the lad area, the rotation speed did not decrease.It was also noted that the diamond coating was peeled off.The device was simply pulled out while the burr was still rotating.The procedure was completed with another of the same device.No patient complications were reported and the patient's condition was good post procedure.

• Brand Name: ROTALINK PLUS
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9769630
• MDR Text Key: 181433710
• Report Number: 2134265-2020-02211
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729316411
• UDI-Public: 08714729316411
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 03/11/2020

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: 04/07/2021
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0023758374
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Initial Date Manufacturer Received: 02/19/2020
• Initial Date FDA Received: 02/28/2020
• Supplement Dates Manufacturer Received: 03/10/2020
• Supplement Dates FDA Received: 03/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1