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

Model Number 3241

Device Problem Entrapment of Device (1212)

Patient Problem Stroke/CVA (1770)

Event Date 09/10/2020

Event Type  Injury  

Event Description

It was reported that the burr became stuck on the guidewire and a stroke occurred.A 1.25mm rotalink plus with rotawire were selected for use in the percutaneous coronary intervention (pci) procedure.During the procedure, the burr became stuck on the guidewire and it could not be removed.The catheter and the wire were removed together as one unit from the patient.The patient was transferred to emergency surgery and received a coronary artery bypass grafting (cabg).Then, the patient had a stroke.

Manufacturer Narrative

Device evaluated by manufacturer: the rotalink plus and rotawire were returned for analysis.The wire was able to be removed with some minor resistance.The burr catheter was attached to the advancer when received.The advancer, handshake connection, sheath, coil, burr and annulus were microscopically and visually examined.Visual examination revealed that the coil was stretched and kinked at the handshake connection.Microscopic examination revealed damage to the annulus.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found damage that could have contributed to the reported event.

Event Description

It was reported that the burr became stuck on the guidewire and a stroke occurred.A 1.25mm rotalink plus with rotawire were selected for use in the percutaneous coronary intervention (pci) procedure.During the procedure, the burr became stuck on the guidewire and it could not be removed.The catheter and the wire were removed together as one unit from the patient.The patient was transferred to emergency surgery and received a coronary artery bypass grafting (cabg).Then, the patient had a stroke.

• 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: 10671557
• MDR Text Key: 211093065
• Report Number: 2134265-2020-14042
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729316411
• UDI-Public: 08714729316411
• 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: 11/17/2020

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: 05/31/2022
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0025654839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Initial Date Manufacturer Received: 10/01/2020
• Initial Date FDA Received: 10/13/2020
• Supplement Dates Manufacturer Received: 11/12/2020
• Supplement Dates FDA Received: 11/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention