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

Model Number 3320

Device Problems Break (1069); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/01/2020

Event Type  malfunction  

Event Description

It was reported that the burr sheath was fractured.The 70-80% stenosed target lesion was located in the moderately tortuous and moderate to severely calcified proximal to middle left anterior descending artery.A 1.50mm rotalink burr was selected for use.A balloon showed dog bone condition and could not fully dilate the balloon.During procedure it was noted that the burr sheath was fractured.The device was simply pulled out from the patient's body and noticed to be kinked.The procedure was completed with another of the same device.There were no complications reported and patient was stable.

Event Description

It was reported that the burr sheath was fractured.The 70-80% stenosed target lesion was located in the moderately tortuous and moderate to severely calcified proximal to middle left anterior descending artery.A 1.50mm rotalink burr was selected for use.A balloon showed dog bone condition and could not fully dilate the balloon.During procedure it was noted that the burr sheath was fractured.The device was simply pulled out from the patient's body and noticed to be kinked.The procedure was completed with another of the same device.There were no complications reported and patient was stable.However, it was further reported that the burr sheath got kinked only.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The handshake connection, sheath, burr, and coil were microscopically and visually examined.Inspection of the device revealed that the sheath was separated 22.3cm distal of the strain relief with blood in the sheath.Majority of the coil was stretched, and the handshake connection was received stuck in the housing.The housing was dismantled to check for damage inside the housing and no damage was present.The damage to the sheath is consistent to damage from over tightening the hemostasis valve.

• Brand Name: ROTALINK BURR
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10638126
• MDR Text Key: 210081143
• Report Number: 2134265-2020-13602
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729185857
• UDI-Public: 08714729185857
• 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: 11/05/2020

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: 09/22/2021
• Device Model Number: 3320
• Device Catalogue Number: 3320
• Device Lot Number: 0024644934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Initial Date Manufacturer Received: 09/11/2020
• Initial Date FDA Received: 10/06/2020
• Supplement Dates Manufacturer Received: 10/15/2020
• Supplement Dates FDA Received: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 145