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

Model Number 3241

Device Problem Entrapment of Device (1212)

Patient Problems Cardiac Arrest (1762); Ventricular Tachycardia (2132)

Event Date 02/08/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that the device was stuck in the lesion.The 90% stenosed target lesion was located in a non-severely tortuous and severely calcified left main anterior descending artery.A 1.50mm rotalink plus was selected for use.During the procedure, the target lesion was ablated once for 13 seconds.The set operational speed of the device was 220, 000 rpm.Subsequently, the burr was stuck in the calcified lesion during insertion with dynaglide mode after rotating high speed.The rotalink was removed from the patient by cutting the driveshaft sheath, advancing the guidewire advanced along the device, and using a small diameter balloon to remove the device.The procedure was completed with another of the same device.During hemostasis after percutaneous coronary intervention, the patient developed ventricular tachycardia (vt) and cardiac arrest occurred.It was resolved by cardiac compression.It was noted that the rotablator did not contribute directly to the vt.No further complications reported and patient's condition is good.

Manufacturer Narrative

Initial reporter city: (b)(6).Device evaluated by mfr: the device was returned for analysis.The returned complaint device consisted of the coil and burr with a part of the rotawire in the device.The rotawire was removed with no resistance.The advancer and the rest of the burr catheter were not returned for analysis.The coil and burr were microscopically and visually examined.The coil is stretched and is broken 144.4cm from the burr tip.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

It was reported that the device was stuck in the lesion.The 90% stenosed target lesion was located in a non-severely tortuous and severely calcified left main anterior descending artery.A 1.50mm rotalink plus was selected for use.During the procedure, the target lesion was ablated once for 13 seconds.The set operational speed of the device was 220, 000 rpm.Subsequently, the burr was stuck in the calcified lesion during insertion with dynaglide mode after rotating high speed.The rotalink was removed from the patient by cutting the driveshaft sheath, advancing the guidewire advanced along the device, and using a small diameter balloon to remove the device.The procedure was completed with another of the same device.During hemostasis after percutaneous coronary intervention, the patient developed ventricular tachycardia (vt) and cardiac arrest occurred.It was resolved by cardiac compression.It was noted that the rotablator did not contribute directly to the vt.No further complications reported and patient's condition is good.

• 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: 8382305
• MDR Text Key: 137545256
• Report Number: 2134265-2019-01906
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 04/09/2019

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: 11/03/2020
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 23027498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2019
• Initial Date Manufacturer Received: 02/12/2019
• Initial Date FDA Received: 03/01/2019
• Supplement Dates Manufacturer Received: 03/19/2019
• Supplement Dates FDA Received: 04/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDE CATHETER: 7FJL 3.5 HYPERION; GUIDE CATHETER: 7FJL 3.5 HYPERION; GUIDE CATHETER: 7FJL 3.5 HYPERION
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR