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

Model Number 45007

Device Problem Entrapment of Device (1212)

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

Event Date 03/15/2024

Event Type  malfunction  

Manufacturer Narrative

The returned product consisted of a jetstream xc-2.1 atherectomy catheter.A filter wire was stuck in the device.The device and the catheter shaft were analyzed for damage.Visual examination showed no shaft damage.A non-boston scientific filter guidewire was stuck in the device.The wire was sticking out of the tip approximately 21.5cm and sticking out of the pod approximately 144cm.The tip was run too far distal on the guidewire and was interfering with the spring coils on the guidewire.The device was set up for testing, was primed and ran as designed.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.

Event Description

It was reported that the guidewire became stuck on the device.A 2.1mm jetstream xc atherectomy catheter was used in a lower extremity atherectomy procedure for peripheral artery disease treatment.After two successful passes blades down, and one blades up, the device was unable to be rexed out.The jetstream catheter and guidewire were pulled out at same time, losing wire access.Both devices were removed intact, with no visible damage to the jetstream catheter.A new guidewire was used, and a decision was made to move to a non-boston scientific balloon.The procedure completed successfully, with no patient complications.

• 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: 19061326
• MDR Text Key: 339894021
• Report Number: 2124215-2024-21171
• 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: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2024
• 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: 0031056238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1