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

Model Number 3241

Device Problems Failure to Advance (2524); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)

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

Event Date 03/24/2024

Event Type  malfunction  

Event Description

It was reported that the tip was fractured.The 85% stenosed target lesion was located in the mildly tortuous and severely calcified left anterior descending artery (lad).A 1.50mm rotablator rotalink plus was selected for use.During the procedure, the tip was fractured and the guidewire could not cross.The device was completely removed from the patient along the guidewire and the procedure was completed with another of the same device.No complications were reported and the patient was stable post procedure.

Event Description

It was reported that the tip was fractured.The 85% stenosed target lesion was located in the mildly tortuous and severely calcified left anterior descending artery (lad).A 1.50mm rotablator rotalink plus was selected for use.During the procedure, the tip was fractured and the guidewire could not cross.The device was completely removed from the patient along the guidewire and the procedure was completed with another of the same device.No complications were reported and the patient was stable post procedure.

Manufacturer Narrative

Device evaluated by mfr.: the device was returned for analysis.A visual examination of the device did not identify any damages or defects.A microscopic examination of the device found that the annulus was damaged/not rounded.

• 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 T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19137021
• MDR Text Key: 340524649
• Report Number: 2124215-2024-21991
• Device Sequence Number: 1
• Product Code: MCX
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/28/2024

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 Expiration Date: 04/11/2024
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0029387436
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/18/2024
• Supplement Dates Manufacturer Received: 05/07/2024
• Supplement Dates FDA Received: 05/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2022
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 75 KG