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

Model Number 3241

Device Problems Entrapment of Device (1212); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/22/2021

Event Type  malfunction  

Event Description

It was reported that foreign material was observed on the device and the device entrapment occurred.The target lesion was located in the moderately tortuous and severely calcified right coronary artery.A 1.25mm and a rotawire guidewire were selected for use.During the procedure, the 1.25mm burr was used but the proximal surface of the burr was stuck in the drive shaft sheath.The burr was completely removed from the patient's body together with the rotawire.A 1.5mm rotalink plus burr was selected to continue the procedure but a foreign object was stuck between the burr and the rotawire and the advancer did not move.The 1.5mm rotalink plus burr was also completely removed together with the rotawire and the procedure was completed with nc balloon catheter.No complications were reported and the patient was good post procedure.

Manufacturer Narrative

Device evaluated by manufacturer: returned product consisted of the rotablator rotalink plus atherectomy device.The burr catheter was received attached to the advancer unit.The advancer, handshake connections, sheath, coil, burr and annulus were visually examined.Inspection of the device presented no damage or irregularities.No unusual objects or foreign material were noted on the annulus.The rotawire used in the procedure was also returned.So, functional testing consisted of using the rotawire from the procedure.The wire was inserted into the annulus of the burr and advanced the through the advancer with no resistance or issues.There was no unusual objects or foreign material identified on the wire before or during insertion.Product analysis did not confirm the reported event, as the test wire was able to be inserted and advanced through the burr catheter with no issues, and no unusual objects or foreign material were found before or during testing.

Event Description

It was reported that a foreign object was stuck between the burr and the wire.The target lesion was located in the moderately tortuous and severely calcified right coronary artery.Two rotalink plus with different sizes, 1.25mm and 1.5mm, and a rotawire guidewire were selected for use.During the procedure, 1.25mm burr was used but the proximal surface of the burr was stuck in the drive shaft sheath.The burr was completely removed from the patient's body together with the rotawire.Then, a 1.5 burr was used but a foreign object was stuck between the burr and the rotawire, and the burr did not move.The second burr was also completely removed from the patient's body together with the rotawire and the procedure was completed using non-compliant (nc) balloon.No complications were reported and the patient 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: 11467001
• MDR Text Key: 239417970
• Report Number: 2134265-2021-03125
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729228363
• UDI-Public: 08714729228363
• 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
• Type of Report: Initial,Followup
• Report Date: 07/06/2021

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: 10/25/2022
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0026414049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2021
• Initial Date Manufacturer Received: 02/22/2021
• Initial Date FDA Received: 03/11/2021
• Supplement Dates Manufacturer Received: 06/28/2021
• Supplement Dates FDA Received: 07/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDEWIRE: ROTAWIRE; GUIDEWIRE: ROTAWIRE
• Patient Age: 80 YR