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

Model Number 3320

Device Problems Fluid/Blood Leak (1250); Material Integrity Problem (2978); Intermittent Loss of Power (4016)

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

Event Date 12/14/2022

Event Type  malfunction  

Event Description

It was reported that a crack within the burr occurred.The target lesion was in the left main trunk opening.A 1.50mm rotalink burr was selected for use.During the procedure, it was noted that the wall of the burr was cracked.Fluid was leaking from the location of the crack and the device stalled.The device was not used to complete the procedure.The procedure was completed with another of the same device.No complications reported and the patient is stable.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The handshake connection, sheath, coil, burr and annulus were visually examined.Inspection of the device found that the sheath was torn at 10cm from the burr housing strain relief, and that blood was present within the sheath.Functional testing was performed by connecting the rotablator advancer to the fluid infusion line.When fluid was ran through the device, it was found that fluid leaked from the opening in the sheath.When the advancer was connected to the rotablator console control system and the foot pedal was pressed, the device stalled and would not run due to the blood within the device.

Event Description

It was reported that a crack within the burr occurred.The target lesion was in the left main trunk opening.A 1.50mm rotalink burr was selected for use.During the procedure, it was noted that the wall of the burr was cracked.Fluid was leaking from the location of the crack and the device stalled.The device was not used to complete the procedure.The procedure was completed with another of the same device.No complications reported and the patient is stable.It was further reported that the reason for blood reflux is that there is a break in the wall of the catheter.After entering the body, the rotational ablation fluid flowed out from the break.The stall is also because of the tear in the catheter.

• Brand Name: ROTALINK BURR
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16137292
• MDR Text Key: 307622987
• Report Number: 2124215-2022-55921
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729185857
• UDI-Public: 08714729185857
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/26/2023

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: 04/01/2024
• Device Model Number: 3320
• Device Catalogue Number: 3320
• Device Lot Number: 0029324873
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/22/2022
• Initial Date FDA Received: 01/11/2023
• Supplement Dates Manufacturer Received: 01/11/2023
• Supplement Dates FDA Received: 01/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2022
• 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
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 51 KG