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

Model Number 3320

Device Problems Entrapment of Device (1212); Intermittent Loss of Power (4016)

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

Event Date 12/28/2023

Event Type  malfunction  

Manufacturer Narrative

E1: initial reporter facility name: (b)(6).

Event Description

It was reported that the burr became stuck on the rotawire.The target lesion was located in the moderately tortuous right coronary artery with annular calcification of the right crown.A 1.25mm rotalink burr and a rotawire were selected for percutaneous coronary intervention (pci) procedure.During the procedure, it was noted that the device stalled, which caused the burr was stuck on the rotowire inside the patient and it could not be pushed.There was no resistance to advance but there was resistance during removal.The burr and the rotawire were simply pulled and removed together as one unit from the patient.Then, it was noted that the advancer was leaking gas.The procedure was completed with another same devices.There were no patient complications were reported, the patient was stable and good recovery post procedure.

Manufacturer Narrative

E1: initial reporter facility name: (b)(6) medical university.Device evaluated by mfr.: the device was returned for analysis.The handshake connection, sheath, coil, burr and annulus were visually examined.Inspection of the device found that the coil was kinked at the burr.The rotowire used in the procedure was not returned for analysis.So, functional testing consisted of using a test rotowire.The wire was inserted through the annulus but was not able to pass the damaged coil.Further functional testing was performed using a test rota advancer.When the advancer was connected to the rota console, the advancer stalled and was not able to run due to the damaged coil.Product analysis confirmed the reported events, as the kinked coil prevented the test rotowire from smoothly advancing through the device and prevented the test advancer from rotating.

Event Description

It was reported that the burr became stuck on the rotawire.The target lesion was located in the moderately tortuous right coronary artery with annular calcification of the right crown.A 1.25mm rotalink burr and a rotawire were selected for percutaneous coronary intervention (pci) procedure.During the procedure, it was noted that the device stalled, which caused the burr was stuck on the rotowire inside the patient and it could not be pushed.There was no resistance to advance but there was resistance during removal.The burr and the rotawire were simply pulled and removed together as one unit from the patient.Then, it was noted that the advancer was leaking gas.The procedure was completed with another same devices.There were no patient complications were reported, the patient was stable and good recovery post procedure.

• Brand Name: ROTALINK BURR
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18711192
• MDR Text Key: 335470288
• Report Number: 2124215-2024-04614
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729185864
• UDI-Public: 08714729185864
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/03/2024

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: 3320
• Device Catalogue Number: 3320
• Device Lot Number: 0031537024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2024
• Initial Date FDA Received: 02/15/2024
• Supplement Dates Manufacturer Received: 03/12/2024
• Supplement Dates FDA Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2023
• 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: 78 YR
• Patient Sex: Male
• Patient Weight: 70 KG