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

Model Number 3241

Device Problem Break (1069)

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

Event Date 09/10/2021

Event Type  malfunction  

Event Description

It was reported that a burr shaft break occurred.The target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 1.50mm rotalink plus was selected for use.During the testing phase, it was noted that shaft of the burr catheter tore itself.The device was not inserted inside the patient and the procedure was completed with another of same device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for evaluation.The advancer, handshake connections, sheath, coil, burr and annulus were visually and microscopically examined.Inspection of the device revealed that the sheath was separated at 62cm from the burr housing strain relief.The separated ends of the sheath were stretched and torn.The coil was found to be severely stretched at the handshake connection.The damages to the sheath and coil are consistent to continued pulling of the sheath during rotation of the coil.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

It was reported that a burr shaft break occurred.The target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 1.50mm rotalink plus was selected for use.During the testing phase, it was noted that shaft of the burr catheter tore itself.The device was not inserted inside the patient and the procedure was completed with another of same device.No patient complications were reported.

• 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 CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12561729
• MDR Text Key: 274280303
• Report Number: 2134265-2021-12343
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729228363
• UDI-Public: 08714729228363
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/09/2021

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: 05/31/2023
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0027585757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/10/2021
• Initial Date FDA Received: 10/01/2021
• Supplement Dates Manufacturer Received: 10/28/2021
• Supplement Dates FDA Received: 11/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2021
• 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