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 06/06/2023

Event Type  malfunction  

Event Description

It was reported that a device fracture occurred.The 30mmx2.75mm, 95% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 1.50mm rotablator rotalink plus was selected for use.During unpacking, it was noted that the connection of the grinding head is broken and cannot be pushed.Hence, it was found that the part that connects the advancer and the bur was damaged.The procedure was completed with another of the same device.No complications reported and the patient is stable.

Manufacturer Narrative

E1.Initial reporter facility name-the first affiliated hospital of (b)(6) university.

Event Description

It was reported that a device fracture occurred.The 30mmx2.75mm, 95% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 1.50mm rotablator rotalink plus was selected for use.During unpacking, it was noted that the connection of the grinding head is broken and cannot be pushed.Hence, it was found that the part that connects the advancer and the bur was damaged.The procedure was completed with another of the same device.No complications reported and the patient is stable.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for evaluation.The advancer, drive shaft, and handshake connection were visually and microscopically examined.Inspection of the device found that the advancer handshake connection was bent, and that the burr catheter handshake connection was not visible.In order to examine the burr catheter, the burr housing was dismantled and it was found that the coil was kinked, stretched, and detached within the sheath.Wear was identified within the sheath.E1.Initial reporter facility name-the first affiliated hospital of (b)(6).

• 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: 17550042
• MDR Text Key: 321178843
• Report Number: 2124215-2023-41482
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0029746713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2022
• 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: 59 YR
• Patient Sex: Male
• Patient Weight: 65 KG