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

Model Number 3320

Device Problems Entrapment of Device (1212); Output Problem (3005); Intermittent Loss of Power (4016)

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

Event Date 01/30/2024

Event Type  malfunction  

Event Description

It was reported that the burr became stuck on the rotawire.The 80% stenosed, 32 x 2.50 mm target lesion was located in the moderately tortuous and severely calcified left anterior descending artery (lad).A 1.50mm rotalink burr and a rotawire were selected for percutaneous coronary intervention (pci) procedure.A pecking motion used for burr advancement.During procedure, the burr became stuck on the rotawire, and the rotation speed was at 45,000 rpm, then device stalled inside the patient.There was a significant resistance encountered between the burr and the guidewire during removal.The burr and the rotawire were removed together as one unit from the patient.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable post procedure.

Event Description

It was reported that the burr became stuck on the rotawire.The 80% stenosed, 32 x 2.50 mm target lesion was located in the moderately tortuous and severely calcified left anterior descending artery (lad).A 1.50mm rotalink burr and a rotawire were selected for percutaneous coronary intervention (pci) procedure.A pecking motion used for burr advancement.During procedure, the burr became stuck on the rotawire, and the rotation speed was at 45,000 rpm, then device stalled inside the patient.There was a significant resistance encountered between the burr and the guidewire during removal.The burr and the rotawire were removed together as one unit from the patient.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable post procedure.

Manufacturer Narrative

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 handshake connection was bent.The rotawire used in the procedure was returned and used for analysis.The returned wire was able to be removed with resistance, but was not able to be reinserted due to numerous kinks in the wire.In order to determine the functionality of the burr catheter, a test rotawire was used.During testing, the wire was not able to be inserted beyond the damaged handshake connection.Further functional testing was performed using a test advancer.When the test advancer was connected to the rotapro console control system and the knob switch [ablation button] was pressed, the device stalled and was not able to run due to the damaged handshake connection.

• 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 CORK LIMITED; 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: 18811439
• MDR Text Key: 336992121
• Report Number: 2124215-2024-08445
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729185857
• UDI-Public: 08714729185857
• 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: 04/11/2024

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: 0032014893
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2024
• Initial Date FDA Received: 02/29/2024
• Supplement Dates Manufacturer Received: 03/21/2024
• Supplement Dates FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2023
• 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: 71 YR
• Patient Sex: Female
• Patient Weight: 74 KG