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

Model Number 3241

Device Problems Difficult to Remove (1528); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/18/2023

Event Type  malfunction  

Event Description

It was reported that device was difficult to removed.The 90% stenosed target lesion was located in the severely tortuous and severely calcified lesion left circumflex artery.A second lesion was located in left anterior descending artery.During preparation, resistance was felt while loading the rotablator rotalink plus 1.50mm onto the rotawire.The left circumflex artery lesion was successfully ablated, but while removing the rotablator rotalink plus 1.50mm resistance was felt.The radiopaque tip of the rotawire became separated inside the patient and was not retrieved.The left anterior descending artery lesion was treated with an additional rotablator rotalink plus 1.50mm and rotawire.The procedure was completed successfully and the patient is doing well.

Manufacturer Narrative

A rotablator rotalink plus atherectomy device was returned for analysis.The burr catheter was received attached to the advancer unit.The advancer, handshake connections, sheath, coil, burr and annulus were visually and microscopically examined.Inspection of the device found that the annulus of the burr was damaged/not rounded.As the rotawire used in the procedure was not returned, analysis was performed using a test rotawire.During testing, the rotawire was unable to be inserted beyond the damaged annulus of the burr.Further functional testing was performed by attempting to rotate the drive shaft, and the drive shaft was able to be rotated.When the rotablator advancer was connected to the rotablator console control system and the foot pedal was pressed, the device was able to reach and maintain optimal rpm with no resistance or issues.

Event Description

It was reported that removal difficulty occurred.The 90% stenosed, severely tortuous and severely calcified lesion was located in the left circumflex artery.A second lesion was located in left anterior descending artery.During preparation, resistance was felt while loading the rotablator rotalink plus 1.50mm onto the rotawire.The left circumflex artery lesion was successfully ablated, but while removing the rotablator rotalink plus 1.50mm resistance was felt.The radiopaque tip of the rotawire became separated inside the patient and was not retrieved.The left anterior descending artery lesion was treated with an additional rotablator rotalink plus 1.50mm and rotawire.The procedure was completed successfully and the patient is doing well.

• 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 CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16311502
• MDR Text Key: 308940689
• Report Number: 2124215-2023-04019
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729228363
• UDI-Public: 08714729228363
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0030007106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2023
• Initial Date FDA Received: 02/07/2023
• Supplement Dates Manufacturer Received: 03/09/2023
• Supplement Dates FDA Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2022
• 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
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Race: Asian