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

Model Number 3320

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Aortic Dissection (2491); Vascular Dissection (3160)

Event Date 08/24/2020

Event Type  Injury  

Manufacturer Narrative

Age at time of event- 18 years or older.

Event Description

It was reported that the sheath fractured and caused dissection.The 98% stenosed, 26mmx3.5mm target lesion was located in severely tortuous and severely calcified right coronary artery (rca).A 1.50mm rotalink burr was selected for use.During procedure, it was noted that the sheath of the device was fractured and caused dissection in the rca.The procedure was not completed due to the event.No further complications reported and patient was stable post procedure.

Manufacturer Narrative

A2.Age at time of event- 18 years or older.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 21.4cm distal of the strain relief with blood in the sheath.The annulus was damaged and not rounded.The damage to the sheath is consistent to damage from over tightening the hemostasis valve.This damage would have caused the blood to be able to get inside the sheath and causing damage to the advancer.

Event Description

It was reported that the sheath fractured and caused dissection.The 98% stenosed, 26mmx3.5mm target lesion was located in severely tortuous and severely calcified right coronary artery (rca).A 1.50mm rotalink burr was selected for use.During procedure, it was noted that the sheath of the device was fractured and caused dissection in the rca.The procedure was not completed due to the event.No further complications reported and patient was stable post procedure.It was further reported that the dissection was flow-limiting and was in the most severe grade.Subsequently, complications associated with dissection was noted and the patient was sent for surgery.There were no device fragments left inside the patient's body.

Manufacturer Narrative

A2.Age at time of event 18 years or older.

Event Description

It was reported that the sheath fractured and caused dissection.The 98% stenosed, 26mmx3.5mm target lesion was located in severely tortuous and severely calcified right coronary artery (rca).A 1.50mm rotalink burr was selected for use.During procedure, it was noted that the sheath of the device was fractured and caused dissection in the rca.The procedure was not completed due to the event.No further complications reported and patient was stable post procedure.It was further reported that the dissection was flow-limiting and was in the most severe grade.Subsequently, complications associated with dissection was noted and the patient was sent for surgery.There were no device fragments left inside the patient's body.

• 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: 10574826
• MDR Text Key: 208182106
• Report Number: 2134265-2020-13196
• 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,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/15/2021
• Device Model Number: 3320
• Device Catalogue Number: 3320
• Device Lot Number: 0024433243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Initial Date Manufacturer Received: 09/18/2020
• Initial Date FDA Received: 09/23/2020
• Supplement Dates Manufacturer Received: 09/28/2020; 11/09/2020
• Supplement Dates FDA Received: 10/19/2020; 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention