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

Model Number 45007

Device Problems Difficult to Remove (1528); Air/Gas in Device (4062)

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

Event Date 01/03/2024

Event Type  malfunction  

Manufacturer Narrative

Evaluation by manufacturer: the returned product that was received by boston scientific consisted of a jetstream xc-2.1 atherectomy catheter.The device was visually and microscopically inspected for damage.There was blood in the device.The device showed 2 buckling/kinks on the shaft located 1cm, and 129.3cm from the tip.The device was attempted to be connected to the console per the ifu.The jetstream connector did not connect to the console.Analysis of the connector showed bent pins.Functional analysis of the device could not be completed due to the bent pin damage.A.014 guidewire was inserted into the device and the wire transcended through the device with a restriction due to the shaft damage.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.The complaint for a bubble error was not confirmed; however, shaft damage and bent pins in the connector were confirmed.

Event Description

It was reported the device was difficult to remove over the guidewire.A 2.1mm jetstream xc catheter was selected for an angiogram/atherectomy procedure.The physician noted the device was hard to remove over the guidewire.There were no patient complications, and the case was completed with a different device of the same model.

• Brand Name: JETSTREAM XC
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 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: 18609180
• MDR Text Key: 334139355
• Report Number: 2124215-2024-04310
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 08714729889892
• UDI-Public: 08714729889892
• 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: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0029928808
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1