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

Model Number 3241

Device Problems Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)

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

Event Date 06/05/2023

Event Type  malfunction  

Event Description

It was reported that a device fracture occurred.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified lower extremity femoral artery.A 1.50mm rotablator plus was selected for use.During the procedure, it was noted that the burr was fractured.Hence, the tip was leaking water.The device was removed simply without any intervention done and the procedure was completed with another of the same device.There were no complications reported and the patient is stable.

Manufacturer Narrative

A3.Weight-86.5kg.E1.Initial reporter address (b)(6).

Manufacturer Narrative

Device evaluated by mfr: the device was returned for evaluation.The device was received with the burr catheter connected to the advancer.The advancer, handshake connections, housings, sheath, coil, burr, and annulus were visually and microscopically examined.Inspection of the device found that the sheath was torn, and that the coil was kinked and stretched at 19cm from the burr housing strain relief.Functional testing was performed by connecting the rotablator advancer to fluid infusion.When fluid infusion was started, fluid leaked from the torn sheath in accordance with the reported events.A3.Weight-86.5kg.E1.Initial reporter address 1 (b)(6).

Event Description

It was reported that a device fracture occurred.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified lower extremity femoral artery.A 1.50mm rotablator plus was selected for use.During the procedure, it was noted that the burr was fractured.Hence, the tip was leaking water.The device was removed simply without any intervention done and the procedure was completed with another of the same device.There were no complications reported and the patient is stable.

• Brand Name: ROTALINK PLUS
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17280174
• MDR Text Key: 318680635
• Report Number: 2124215-2023-32683
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729228363
• UDI-Public: 08714729228363
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 09/05/2023

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 Expiration Date: 05/16/2024
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0029602169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2023
• Initial Date FDA Received: 07/07/2023
• Supplement Dates Manufacturer Received: 08/15/2023
• Supplement Dates FDA Received: 09/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2022
• 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: 71 YR
• Patient Sex: Male