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

Model Number 3241

Device Problem Entrapment of Device (1212)

Patient Problem Vasoconstriction (2126)

Event Date 07/05/2021

Event Type  Injury  

Manufacturer Narrative

Age at time of event: 18 years or older.

Event Description

It was reported that the burr was stuck to the lesion.Vascular access was obtained via femoral artery.The 80% stenosed, 24mmx3.00mm, eccentric, de novo (progressive) target lesion was located in the mildly tortuous and severely calcified left anterior descending artery.A 1.25mm rotalink plus was selected for use.During the procedure, the target lesion was predilated using a non-boston scientific balloon but the balloon burst upon inflation due to calcification.The physician then decided to use the rotablator and proceeded to rewire using a rotawire.The physician used a rotalink 1.50mm and after performing ablation for 2 runs, opted to change to rotalink 1.25mm to further optimize the lesion.The rotalink 1.25mm passed through the lesion on the first run and could not be retrieved after, as the burr was stuck distal to the lesion.Nitro was injected to relieve any spasms to the vessel that might have caused it but it did not help in retrieval of the rotalink device.A new non-boston scientific balloon was also dilated at the lesion to facilitate the removal of the rotalink 1.25mm but it was to no avail.The patient was sent for surgery and the burr was completely removed.No further complications were reported and the patient is stable post surgery.

• Brand Name: ROTALINK PLUS
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12197732
• MDR Text Key: 262490834
• Report Number: 2134265-2021-09250
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729316411
• UDI-Public: 08714729316411
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/20/2021

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: 06/10/2022
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0025698649
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/09/2021
• Initial Date FDA Received: 07/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BALLOON CATHETER - SAPPHIRE II 1.5X10; GUIDE CATHETER - LAUNCHER EBU3.5 7F; GUIDEWIRE - ASAHI SION BLUE
• Patient Outcome(s): Other; Required Intervention