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

Model Number 3241

Device Problems Difficult to Remove (1528); Infusion or Flow Problem (2964); Output Problem (3005)

Patient Problem No Code Available (3191)

Event Date 11/14/2019

Event Type  Injury  

Event Description

It was reported that the device was difficult to remove.A 1.50 mm rotalink plus was selected for a procedure in the 70% stenosed, 85% calcified, and moderately tortuous coronary artery.During the procedure, the burr stopped rotation and the system was stalled.Blood was observed within the infusion tubing.Troubleshooting attempts were made by testing the rotation, viewing air pressure, and turning the console on and off.There was severe resistance felt during removal.Nitroglycerin was administered and the burr was able to be removed with a maneuver.There were no patient complications and the patient was stable post procedure.

Manufacturer Narrative

Device eval by manufacturer: the returned complaint device consisted of a rotablator rotalink plus device.The burr catheter was received attached to the advancer unit along with a rotawire in the device.The rotawire was removed with little resistance due to multiple wire kinks.The advancer, handshake connections, sheath, coil, burr and annulus were visually and microscopically exanimated.There was blood in the sheath and in the housings.The coil was stretched and kinked at the handshake connection.Functional testing was performed by attempting to rotate the drive shaft.The device was unable to rotate due to a melted ultem.A melted ultem is due to the interruption of saline or by insufficient flow of saline used during preparation or during procedure.Saline is used in the clinical setting to cool and lubricate the moving parts and prevents a melted ultem, ensuring the functional use of the device.

Event Description

It was reported that the device was difficult to remove.A 1.50 mm rotalink plus was selected for a procedure in the 70% stenosed, 85% calcified, and moderately tortuous coronary artery.During the procedure, the burr stopped rotation and the system was stalled.Blood was observed within the infusion tubing.Troubleshooting attempts were made by testing the rotation, viewing air pressure, and turning the console on and off.There was severe resistance felt during removal.Nitroglycerin was administered and the burr was able to be removed with a maneuver.There were no patient complications and the patient was stable 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: 9483570
• MDR Text Key: 171893516
• Report Number: 2134265-2019-15868
• 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: 01/29/2020

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 Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0024108635
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2019
• Initial Date Manufacturer Received: 11/26/2019
• Initial Date FDA Received: 12/17/2019
• Supplement Dates Manufacturer Received: 01/14/2020
• Supplement Dates FDA Received: 01/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention