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

Model Number 45007

Device Problems Entrapment of Device (1212); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 01/30/2024

Event Type  malfunction  

Event Description

It was reported that this device became entrapped on the guidewire.This 2.4mm jetstream xc atherectomy catheter was selected for use in an atherectomy procedure.During the procedure, the device was being used with a non-boston scientific filter guidewire.Then the jetstream device could no longer be retracted from the guidewire; therefore, the devices were removed together.It was noted that atherectomy lubricant was not used.During use, the tip of the guidewire was 10cm from the distal tip of the jetstream catheter.There were no patient complications.

Manufacturer Narrative

Device eval by manufacturer: upon receipt at our post market quality assurance laboratory, this jetstream xc atherectomy catheter was returned with a non-boston scientific filter guidewire stuck in the device.The device and the catheter shaft were analyzed for damage.Visual examination showed buckling/kink located 1cm from the tip.The guidewire was sticking out of the tip approximately 4cm and sticking out of the pod approximately 176cm.The device was set up per the instructions for use and the device primed; however, no blade rotation was present 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 was confirmed for guidewire sticking and shaft damage.

Event Description

It was reported that this device became entrapped on the guidewire.This 2.4mm jetstream xc atherectomy catheter was selected for use in an atherectomy procedure.During the procedure, the device was being used with a non-boston scientific filter guidewire.Then the jetstream device could no longer be retracted from the guidewire; therefore, the devices were removed together.It was noted that atherectomy lubricant was not used.During use, the tip of the guidewire was 10cm from the distal tip of the jetstream catheter.There were no patient complications.It was further reported that the procedure was completed using this device.

• Brand Name: JETSTREAM XC ATHERECTOMY CATHETER
• 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: 18791557
• MDR Text Key: 336365152
• Report Number: 2124215-2024-10345
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• 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: 0032643999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1