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

Model Number 45007

Device Problems Entrapment of Device (1212); Detachment of Device or Device Component (2907); Noise, Audible (3273)

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

Event Date 02/14/2022

Event Type  malfunction  

Event Description

It was reported that guidewire entrapment and catheter fracture occurred.The target lesion was located in a complete total occlusion region proximal to the moderately calcified left superficial femoral artery.A 2.4mm jetstream xc atherectomy catheter and non-bsc filterwire were selected for the atherectomy procedure.During the procedure, the physician reported hearing a binding noise that indicated strain on the device.The physician continued operating slowly as it was suspected the device was performing in the complete total occlusion region.The jetstream xc atherectomy catheter then stopped working.When the physician checked the placement of the sheath, it was noted that the sheath had kicked out.The catheter was also entrapped on the guidewire.It was noted that there was a fracture in the middle of the catheter which occurred prior to removal from the body.The catheter and filterwire were remove together.The procedure was completed with a balloon angioplasty using a non-boston scientific guidewire and a 6mm x 200mm x 135cm charger balloon catheter.There were no patient complications reported.

Manufacturer Narrative

Device evaluation by manufacturer: returned product consisted of a jetstream xc-2.4.The device and the catheter shaft were analyzed for damage.The catheter shaft showed a severe kink/fracture of the catheter shaft located 48.5cm from the tip.The drive coil was protruding from the shaft at this location.The device was set up per the ifu.The baton was cut from the device from the customer site.The device could not be functionally tested due to the baton missing.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.

• Brand Name: JETSTREAM XC
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13686437
• MDR Text Key: 286935931
• Report Number: 2134265-2022-02475
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 08714729889922
• UDI-Public: 08714729889922
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133023
• 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: 03/07/2022

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: 05/18/2023
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0027509300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2022
• Initial Date FDA Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MEDTRONIC SPIDERFX FILTERWIRE
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Race: White