MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION; CATHETER, PERIPHERAL, ATHERECTOMY

Lot Number 0032092038

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

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

Event Date 01/03/2024

Event Type  malfunction  

Event Description

It was reported that a device entrapment occurred.The 100% stenosed target lesion was located in the mildly tortuous and calcified posterior tibial artery.A 1.75mm rotapro and a rotawire were selected for use.During the procedure, when advancing the burr through the lesion, the burr was not spinning, and the wire was flopping on the back table indicating that the burr was stuck on the wire.The burr and wire were removed together as one unit.There seemed to be an intimal tissue wrapped around the catheter tip when removed, that was suspected to be the cause of the device became stall and stuck.The procedure was completed with another of the same device.There were no patient complications reported post procedure.

• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC; 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: 18619316
• MDR Text Key: 334283217
• Report Number: 2124215-2024-01814
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 0032092038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 6F 90CM SHEATH
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Race: Black Or African American